Controls Manager Salary in San Mateo, CA

JOB DESCRIPTION As a 100% employee-owned contractor, when you work at Sundt, you're not just hiring on at a company, you're joining a culture. Because everyone at Sundt is part owner, you'll join a team of people who are deeply invested in their work. From apprentices to managers, we're passionate about the details and deliberate in everything we do.At Sundt we focus on building long-term prosperity for our clients, communities and employee-owners. We offer competitive pay, industry-leading benefits including a 401k and employee stock ownership plan, incentive programs for craft and administrative employees as well as training that focuses on your personal and professional growth. We're driven by skill, grit and purpose. Join us as we strive to be the most skilled builder in America.Job SummaryThe Scheduling Engineer will provide technical assistance in creating and updating CPM schedules at all phases of each project throughout their duration, from conceptual to close-out. You will be Sundt Construction's in-house scheduling expert, including coordinating the CPM schedule creation and updating tasks directly with the project superintendent. The Scheduling Engineer produces and delivers various reports from the CPM schedule to the project team and may supervise one or more scheduling engineer assistants. The Scheduling Engineer position includes 2 steps based on experience in the function which are as follows:- Scheduling Engineer I - 3-5 years CPM scheduling experience in similar types of construction.- Scheduling Engineer, Sr. - 5+ years CPM scheduling experience in similar types of construction.Key Responsibilities1. Assists in the development of claims by providing analysis of project CPM schedule performance.2. Assists the Project Superintendent with the incorporation into the CPM schedule the effects form design conflicts and clarifications.3. Assists the project superintendent with the management of the CPM schedule for the successful execution of the work, including the coordination of the means and methods, manpower, equipment and material resources required to accomplish this goal.4. Conducts project CPM schedule review meetings at each of proposal, baseline and update phases.5. Creates the baseline schedule based on logic and sequence information provided by the project superintendent.6. Develops proposal phase CPM schedules from project information provided by the estimating team and historical database.7. Produces a final as-built CPM schedule at the completion of each project.8. Provides reports each month to the general manager indicating the status of the CPM schedule for each project.9. Regularly updates and maintains the historical CPM schedule database.10. Revises each project CPM schedule on a weekly basis from reports completed by the project superintendent.Minimum Job Requirements1. Excellent communication, organizational and supervisory skills are essential.2. Five years or more of CPM scheduling experience in similar types of construction.3. Four year construction management or engineering degree or equivalent combinations of technical training and/or related experience.4. Proficient use of all Microsoft Office Suite programs.5. Thorough knowledge of all aspects of construction (technology, equipment, and methods), scheduling systems, negotiations, engineering and cost control schedules.Note: Job Description is subject to change at any time and may include other duties as assigned. Physical Requirements1. Ability to wear personal protective equipment is required (including but not limited to; steel toed shoes, gloves, safety glasses, hearing protection, hardhat, vest, etc.)2. May reach above shoulder heights and below the waist on a frequent basis3. May stoop, kneel, or bend, on an occasional basis4. May use telephone, computer system, email, or other electronic devices on a limited basis to communicate with internal and external customers or vendors5. Must be able to comply with all safety standards and procedures6. Occasionally will climb stairs, ladders, etc.7. Required to use hands to grasp, lift, handle, carry or feel objects on a frequent basis8. Will interact with people frequently during a shift/work day9. Will lift, push or pull objects on an occasional basis10. Will sit, stand or walk short distances for up to the entire duration of a shift/work day.Safety LevelSafety-SensitiveNote: Jobs with the Safety-Sensitive designation are those that include tasks or duties that the employer reasonably believes could affect the safety and health of the employee performing the task or others such as operating a vehicle, operating equipment, operating machinery or power tools, repairing/maintaining the operation of any vehicle/equipment, the handling/disposal/transport of hazardous materials, or the handling/treatment/disposal of potentially flammable/combustible materials.Equal Opportunity Employer Statement: Sundt is committed to the equal treatment of all employees, and/or applicants for employment, and prohibits discrimination based on race, religion, sex (including pregnancy), sexual orientation, gender identity, color, age, disability, national origin, covered veteran status, genetic information; or any other classification protected by applicable Federal, state, or local laws. #LI-RP1Please note that the compensation information that follows is a good faith estimate and for this position only. It is provided pursuant to the California Equal Pay for Equal Work Act and Equal Pay Transparency Rules for positions located in California. The following pay range is based on geographical market data and does not include additional incentives that can impact total compensation. Salary is commensurate with knowledge, skills, education, and overall job-related experience. Pay Range $100,000-$145,000Benefit list:Market Competitive Salary (paid weekly)Bonus Eligibility based on company, group, and individual performanceEmployee Stock Ownership Plan & 401KIndustry Leading Health Coverage Starting Your First DayFlexible Time Off (FTO)Medical, Health Savings, and Wellness creditsFlexible Spending AccountsEmployee Assistance ProgramWorkplace Wellness ProgramsMental Health ProgramLife and Disability InsuranceEmployee-Owner PerksEducational AssistanceSundt Foundation - Charitable Employee-Owner's program

Innova Solutions is immediately hiring a Project Manager - I Position type: Full-time Contract Duration: 6 months and possibility for extension Location: Foster City CA As aProject Manager - I, you will:1. Author, review and update Business Requirement documents, Specifications, Standard Operating Procedures (SOPs), Change Controls, Master Data Requirements, Migration Plans in adherence to Good Document Practices (GDP). 2. Gather and segregate requirements from Business team and document them into specifications, reports and coordinate the review & approval process in GVault. 3. Planning Supply Chain System CR / Break Fix / Enhancement Tracking a. Management meeting attendance and meeting minutes b. Tracking of status on CR Board c. Communication of status, upcoming deadlines and needs, and communication outward to whomever is beneficial or required. 4. NST Weekly Status Report a. Review and maintenance of NST Task Assignment Board with issues/needs surfaced at Standups or with Sub-Team Leads b. Preparation and creation of ppt Weekly Status Report Deck 5. NST Weekly Meeting (usually Monday afternoon) a. Creation of weekly agenda with input from Team leads and Team Members b. Hosting of Meeting and sending meeting notes, including actions to follow up. 6. Timesheet/Training requirements management 7. BS PTD SC Meetings (Mon / Thu) a. Proactive communication and coordination with IT manager weekly b. Updating of weekly report deck to ensure all NST-related slides are current and complete. 8. Defect & Script Tracking and Communication 9. Data Cutover Tracking and Communication. Required Years of Experience: 2 - 5 years Required Degree or Certification: Bachelor Top 3 Required Skill Sets: Project Management, ERP master data management, Documentation management Top 3 Nice to Have Skill Sets: SAP/RR/EBS go live; team management; Host for workshop and group meetings Unique Selling Point of this role: Exploring the SAP/RR project management experience Any Disqualifiers?: Time commitment APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you! Vishnu Kaushik Email: [email protected] Phone - 678-207-5230 PAY RANGE AND BENEFITS: Pay Range*: $60 - $67 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

About UsSagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet's lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. For additional information about Sagimet, please visit www.sagimet.com.Position SummaryCollaborate with the Clinical Development Team in clinical trial sample management including the strategy, planning, and vendor oversight of the processing, tracking, and reconciliation of biomarker, PD, PK, and other types of biological samples, collected for an assigned project.The Sample Manager will be an integral member of the program team, responsible for the oversight of trial sample operations, managing end-to-end operational planning, including vendor set-up, logistical planning, and coordination, to ensure high-quality sample collection, processing, shipping, receiving, analysis and storage of clinical trial samples in accordance with protocol requirements, ICH GCP guidelines, regulatory requirements, third party lab/analysis vendor specifications, and Sagimet procedures.Clinical Sample Management, Key ResponsibilitiesAccountable for the oversight and supervision of clinical trial sample management: planning, processing, tracking, coordination, reconciliation, and life-cycle management to maintain chain-of-custody in a GxP compliant setting.Leads logistical execution of sample processing, shipping, and timelines associated with sample testing, transfer, and analysis for study deliverables in coordination with Clinical Operations/Biomarker Lead/Clinical Pharmacology Lead, clinical sites, external lab vendors, and couriers. Ensures process is appropriately managed from time of sample collection through delivery of results and long-term sample storage.Develops and reviews lab manuals/requisition forms, lab specifications, kit builds, SOPs, sample labels and other controlled documents related to sample management.Produces and disseminates sample status updates and tracking reports for internal and external use.Ensure stakeholder alignment on clinical trial objectives.Manages external clinical trial sample processing laboratories and vendors and effectively builds standard procedures with service providers to optimize execution.Performs regular budget reconciliation with sample processing laboratories.Supports data transfer specification/agreement drafting to align with the testing objectives, and management of final long-term storage or future use approval of clinical samples.Informs leadership of any quality deviations for clinical sample testing. Actively collect, interpret, review, and document quality deviations for clinical sample handling or testing in the appropriate system.Responsible for reviewing TMF filing documents that originate from lab vendors, in accordance with regulatory requirements.QualificationsBachelor's Degree or international equivalent in life sciences with 4+ years of experience in the pharma industry managing sample logistics.Experience establishing sample management oversight strategies and sample tracking systems for a large international program.Sample Vendor Management Experience (PK/PD, tissue and imaging)Experience managing Global International logistics (e.g. customs, import/export Licenses, insurance etc.) associated with sample shipments from clinical sites to central labs and to third party labs as required.Solid understanding of GLP, GCP-ICH and/or GCLP guidelines, and knowledge of product development processes.Successful experience in supporting globally operating multi-functional teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors).Collaborative self-starter who can balance the needs of an agile company with the requirements of a structured clinical testing environment.Proven ability to communicate and collaborate effectively within and across teams.Experience interacting with external collaborators with the ability to build strong relationships.Knowledge of risk management, project reporting, and project management tools.Strong interpersonal skills.Excellent organization, verbal, and written communication skills to facilitate operational excellence throughout study conduct.Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.CompensationThe expected base salary range for this role is $132,000 - $165,000 Compensation will be based on a variety of factors, including experience, qualifications, and internal equity. Sagimet offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Notice to Recruiters/Staffing AgenciesRecruiters and staffing agencies should not contact Sagimet through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with Sagimet prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with Sagimet and Sagimet will not be responsible for any purported fees.

Innova Solutions is immediately hiring for an Project Manager (Laboratory Operations)Position type: Full-time; Contract Duration: 18+ Months Location: Foster City, CA Pay range: $70 - $75/hr on W2As a Project Manager (Laboratory Operations) Professional you will:Job Description: The LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects. Additional projects may also include process-improvements related to lab functions. Job Responsibilities Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements. Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements. Ensure timely procurement of purchases by obtaining and reviewing quotes, facilitating WOs and POs, and following-up on shipping & delivery status. Facilitate the demonstration of new laboratory systems as needed. Team-up with Facilities Operations in site planning and preparation for instrument installations, including site assessments and communicating engineering/utility requirements. Collaborate with validation team members during qualification activities for GMP systems. Review documents pertaining to system implementations, including installation requirements, protocols, procedures, work instructions, and guidelines. Produce critical project documentation, including timelines in Microsoft Project, project charters, WBS, Teams communications, status update e-mails, PowerPoint presentations, lessons learned, etc. Communicate project requirements, goals, and timelines effectively via weekly project and team meetings. Assist in key project decision making efforts. Present project summaries and status updates to large groups through PowerPoint and verbal communication Organize meetings with vendors and the Vendor Service Team as needed. Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts when applicable The ideal candidate will have: Experience in managing laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.Thank you! PATHAN? SAMIULLAHKHAN Lead - Recruitment (+1) 971-925-2783PAY RANGE AND BENEFITS: Pay range: $70 - $75/hr*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Innova Solutions is immediately hiring for a Project Manager - II Position type: Full time time Contract Duration: 18 months Location: Foster City, CA As a Project Manager - II, you will: Job Description: LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects. Additional projects may also include process-improvements related to lab functions. Job Responsibilities • Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements • Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements • Ensure timely procurement of purchases by obtaining and reviewing quotes, facilitating WOs and POs, and following-up on shipping & delivery status • Facilitate the demonstration of new laboratory systems as needed • Team-up with Facilities Operations in site planning and preparation for instrument installations, including site assessments and communicating engineering/utility requirements • Collaborate with validation team members during qualification activities for GMP systems • Review documents pertaining to system implementations, including installation requirements, protocols, procedures, work instructions, and guidelines • Produce critical project documentation, including timelines in Microsoft Project, project charters, WBS, Teams communications, status update e-mails, PowerPoint presentations, lessons learned, etc. • Communicate project requirements, goals, and timelines effectively via weekly project and team meetings • Assist in key project decision making efforts • Present project summaries and status updates to large groups through PowerPoint and verbal communication • Organize meetings with vendors and the Vendor Service Team as needed • Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts when applicable Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Namrata Gautam Senior Associate Recruitment PHONE: (+1) 314-523-1818 EMAIL: [email protected] PAY RANGE AND BENEFITS: Pay Range*: $70- $75 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Description:Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These >100pages BRR.?Perform review/release of executed batch records.?Perform review/approval of various packaging documents as it applies to CXO (Contract Manufacturing /Packaging Organization.?Interface with CXO in support of routine manufacturing/packaging activities.?Performs a variety of activities to ensure compliance with applicable regulatory requirements.?Adhere to programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). ?Reviews manufacturing/packaging control data for in process and finished products. ?Review and provide information relevant to manufacturing/packaging of product at the CXO for the writing of the annual product reviews.?May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured/packaged products. ?Works with cross-functional teams during new product start-ups and product launches and identifies checkpoints for new products and processes.?Normally receives very little instruction on routine work, general instructions on new assignments.Skills:Quality assurance, Gmp, Batch record, Capa, Batch record reviewQualifications:Specific product knowledge: Pharma products in general, finished goods - not API. This is a packaging review - a lot of common sense or dealing with complex biologics. Reviewing labeling.?Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).?Demonstrates working knowledge of quality assurance systems, methods and procedures.?Demonstrates knowledge of FDA / EMEA standards and quality systems.?Demonstrates basic knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.?Demonstrates audit and investigation skills, and report writing skills.?Demonstrates good verbal, written, and interpersonal communication skills. ?Demonstrates working proficiency in Microsoft Office applications.Education and Experience?4+ years of relevant experience in a GMP environment related field and a BS.?2+ years of relevant experience and a MS.?Prior experience in pharmaceutical industry is preferred.Experience Level:Intermediate LevelAbout ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

Validation Engineer, Labware LIMSFoster City, VALength: year to start, likely extensionsResponsibilitiesValidation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)Validation testing strategy in accordance with Gilead's policy and proceduresclosely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projectswith understanding the business requirements, analyze and help translate into functional requirements for assigned LIMS projectsclosely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS applicationreview & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projectsfor Qualification protocols execution and final report view and approval for LIMS projects"Data Integrity" related- risk assessments,investigations suggest implementing remediations in CGMP operations.Data Integrity compliance/impact assessments, risk assessments, and create short executive summary reports.with the external partner or internal site to assess their DI maturity state and document the results of the assessment.Required Experience / Skills:of 6-10+ years of experience (Hiring for multiple roles Junior, Mid and Senior levels) working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.to master technical content through interaction with subject matter experts.communication and interpersonal skills.Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.of programming and relational database concepts is required.Required Education:BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.

Job Title - Project Manager - II Contract roleLocation - Foster City, CADescription:Laboratory Operations (LabOps) Project ManagerThe LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects. Additional projects may also include process-improvements related to lab functions.Job Responsibilities• Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements• Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements• Ensure timely procurement of purchases by obtaining and reviewing quotes, facilitating WOs and POs, and following-up on shipping & delivery status• Facilitate the demonstration of new laboratory systems as needed• Team-up with Facilities Operations in site planning and preparation for instrument installations, including site assessments and communicating engineering/utility requirements• Collaborate with validation team members during qualification activities for GMP systems• Review documents pertaining to system implementations, including installation requirements, protocols, procedures, work instructions, and guidelines• Produce critical project documentation, including timelines in Microsoft Project, project charters, WBS, Teams communications, status update e-mails, PowerPoint presentations, lessons learned, etc.• Communicate project requirements, goals, and timelines effectively via weekly project and team meetings• Assist in key project decision making efforts• Present project summaries and status updates to large groups through PowerPoint and verbal communication• Organize meetings with vendors and the Vendor Service Team as needed• Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts when applicable