Validation Engineer Salary in St. Louis, MO

Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find treatments for cancer. Location/Division Specific InformationLocation: US - St. Louis, Missouri, site basedDivision: PSG - BiologicsIn the Biologics business unit of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative large molecule therapies. Placed in the forefront of our leading and groundbreaking businesses enabling clients to change lives with therapeutics for often unmet needs. How will you make an impact?The Manufacturing Sciences and Technology (MSAT) Director is responsible for leading all facets of Process Validation, Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP). They will have a strong leadership and scientific mentorship to the MSAT team to ensure robust and reliable production processes are established through a meticulous technology transfer process to enable the site to meet and/or exceed client delivery commitments.This role will drive the planning, execution and customer interaction for the MSAT function during technology transfer from process development through to Commercial manufacturing. They will be accountable for all aspects of implementing, validating and monitoring robust and efficient manufacturing processes to produce human clinical trial and commercial products.What will you do? Leads the Manufacturing Science and Technology team and is responsible for process related activities enabling Drug Substance manufacturing of Biologic's.Is responsible for facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.Is responsible for Process Validation and Continued Process Verification activities.Supports manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise in the Drug Substance fieldProvides strong technical leadership to process engineers, scientists and associates for clinical and commercial production.Coordinates scientifically and/or technically based process improvements of clinical and commercial manufacturing processes. Offers molecule steward and drive process lifecycle management initiative in accordance to customer's molecular strategy as needed.Actively liaises with external customers and internal partners to facilitate execution of customer projects.Operate as key point of contact for Joint Steering Committees engaging with senior level executives both internally and externally.Represent the St. Louis site as a domain expert during external and internal regulatory compliance inspections.Support the authoring, reviewing and approving of regulatory applications for customers as well as support responses to regulatory agencies.Build and responsibly manage operational budgets for the MSAT organization of the site.Responsible for recruitment and development of MSAT staff, ensuring effective utilization of resources through strong leadership, performance management and robust employee development plans.Drive continuous improvements and establish best-in-class MSAT capabilities by improving the enabling processes and systems.Works multi-functional with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments to effectively transfer, maintain and commercialize processes in the facility.Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.Requirements:PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 8 years of relevant experience; orM.S./M.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 12 years of relevant experience; orB.S./B.A. in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 14 years of relevant experience.Knowledge, Skills, Abilities7+ years in a leadership role of sciences / technology groups in a fast-paced production environment.Broad experience in all process areas (Upstream cell culture, downstream processing, buffer and media preparation) and ancillary processes (CIP, SIP).Proficiency in working with multicultural and cross-disciplinary project teamsGood GMP knowledgeCustomer-centric mentalityExperience in leading teamsExcellent organization, planning, problem solving and critical thinking skillsExcellent writing, communication and presentation skillsEnergy and drive (committed, drive for results)Willingness to travel up to 10%Benefits:We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one distributed team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.EEO/Reasonable Accommodation:Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and chip in to our singular mission-enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status

Equifax is a leading financial technology organization committed to delivering innovative and secure solutions. We are seeking a talented Security Solutions Architect with expertise in designing and implementing secure solutions that comply with Equifax and FedRAMP requirements. Join our dynamic team and contribute to the security and success of our federal projects! Sponsorship is not available for this position. Equifax has a hybrid work schedule that allows for 2 days of remote work (Monday and Friday), with 3 days onsite (Tuesday, Wednesday, Thursday) each and every week. This resource will be required to work from one of the following Equifax office locations - Saint Louis, Alpharetta, Atlanta, or Reston. What You'll Do Collaborate with project teams to design and implement secure solutions that align with Equifax and FedRAMP requirements. Lead the architecture and design of security controls for cloud-based and on-premises environments. Translate security and technical requirements into actionable guidance. Conduct technical risk assessments and provide recommendations for mitigating security risks in compliance with FedRAMP standards. Work closely with cross-functional teams to ensure security is integrated into all phases of the system development life cycle. Provide technical leadership in the evaluation and selection of security technologies and tools. Develop and maintain comprehensive security architecture documentation, including system diagrams and security control mappings. Participate in security reviews; support audits, and assessments to ensure ongoing compliance with FedRAMP and other relevant security standards. Stay abreast of industry trends, emerging threats, and new security technologies to continually enhance security architecture. Communicate security risks and solutions to different audiences ranging from business leaders to engineers. Drive automation efforts for the implementation and validation of security controls to ensure products meet and maintain compliance with security requirements. Champion security best practices to highly technical teams as well as mentor team members and those in other technical roles who are critical to the successful delivery of Equifax's cybersecurity strategy. What experience you'll need 7+ yrs of overall experience in security architecture, application security, cloud security, network security, and/or systems security. 5+ yrs of experience in a Security Architecture role, with a focus on FedRAMP compliance. 3+ yrs of experience with and a strong foundational understanding of secure software engineering principles. 2+ yrs of experience with major cloud service offerings (Google, AWS, Azure) and related security controls. 2 + yrs of experience working closely with technical teams to clearly communicate threats and architect solutions. Extensive knowledge of FedRAMP controls, policies, and procedures. Proven experience designing and implementing secure solutions for cloud environments (e.g., AWS, Azure, or Google Cloud). In-depth understanding of security architectures, network protocols, and encryption protocols. Familiarity with federal security frameworks such as NIST, FISMA, and other relevant standards. Excellent communication and presentation skills with the ability to convey complex security concepts to technical and non-technical stakeholders. What could set you apart Strong expertise in conducting risk assessments and developing risk mitigation strategies. Certifications such as CISSP, CISM, GCP PCA, AWS Certified Solutions Architect, or other relevant certifications are highly desirable. Well versed in compliance, security standards, and guidelines including: SOX, NIST, CIS, ISO 27001/2, PCI DSS. Proven understanding of security controls and technologies including SIEM, DLP, WAF, IPS, and firewalls. Able to automate/script daily tasks through Python, bash, or equivalent. Experience with one or more of the following programming languages: C#, Java, C/C++ and/or Python. #LI-Hybrid#LI-KD1

Job DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Location/Division Specific InformationWork Location: St. Louis, MO (on-site)Group: Pharma Services GroupDivision: Drug Substance DivisionHow will you make an impact?We are searching for a Manager, Manufacturing Sciences with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes. The Manager, Manufacturing Sciences routinely supports the Process Engineering team as technical owners of customer programs in a manufacturing environment and will be highly involved and act as a subject matter expert in defining and shaping Thermo Fisher Scientific's own technology programs.This role will collaborate with internally with supervisors/managers and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and with the client as a Process Engineer program lead or as a Process Engineering subject matter expert. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success. What will you do?Draft, review and approve Standard Operation Procedures, and Job Aids and consult internally to ensure scientifically sound and robust procedures. Collaborate with the process development to develop standardized methodologies and learn/explore/initiate new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification. Contribute to Internal and Customer meetings based upon sound evidence without supervision. Initiate and lead internal projects and lead client projects and manage timelines with minimal support from supervision. Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures without supervision. Provide scientific expertise for GMP deviations by assessing, reviewing and approving the impact of major deviations on both the product quality and the validation of the process or consults the process engineering team and internal teams on product impact. Initiate and lead changes to equipment and process design, proactively and without supervision. Consult on non-standard/challenging process design and/or validation strategies. Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing. Draft, review, and approve Process control documents, campaign summary report and process validation reports. Acts as subject matter expert to troubleshoot design flaws, ensure process design is scientifically sound and robust and within the validated process and regulatory guidelines. Reviews, analyzes and trends process data without supervision Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs. Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility. Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers. Provides development and training for Process Engineers/Scientists. How will you get here?EducationBachelor's degree required in a scientific field, preferably in engineering or the biochemistry field, with 8+ years of experienceMaster's degree with 6+ years of experience or PhD with 3+ years of experience will be consideredExperienceExperience within a GMP Environment / Biologics / Pharma Industry highly preferredExperience in a leadership role is requiredKnowledge, Skills and AbilitiesFollow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment. Ability to self-motivate, prioritize work and time. Demonstrates a foundation in general scientific practices, principles, and concepts. Writes and communicates effectively. Ability to work both independently and as part of a team. Knowledge of current Good Manufacturing Practices and US/EU regulations. Advanced knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus. Proficient in Microsoft Word and Excel. Ability to stand for prolonged periods of time and gown into manufacturing areas. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

The Quality Engineer is responsible for developing, reviewing, and managing the execution of validation activities, and ensuring that the qualifications are consistent with the user's/manufacturer's requirements and quality standards. Interact cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and MaintenanceCreate and execute protocols for equipment, methods, analytical instrumentation, and cleaning, process controls, and facility including but not limited to FAT/SAT/IOQ and PQ documentsUtilize GDP in a GMP atmosphere while generating protocols and reviewing documents. Review and generate closing reports for executed protocolsCreate validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers, and quality assurance staff membersWork through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilitiesDevelop/Establish an overall plan for qualifying new equipment or new/upgraded facility and establishing the proper controls for the introduction of equipment/facility and/or changes under proper quality standards (e.g. FDA, EU, ISO, ISPE, etc.)Identify and establish revalidation requirementsWrite and execute qualification packages, technical reports, and validation master plansDevelop cleaning validation protocols for equipment and facilitiesDevelop clean/dirty hold times This is a Hybrid role requiring 3 days per week onsite. Minimum Qualifications:Bachelor's Degree in Biomedical Engineering, Chemical Engineering, Chemistry, or Biochemistry Preferred Qualifications:2+ years of experience in quality or a quality support role2+ years of experience with equipment or validation, in a cGMP manufacturing setting or related industrial laboratory environmentAbility to utilize GDP during document creation and reviewWorking knowledge of current regulatory guidelines and standardsAbility to apply and incorporate regulatory standards, rules, and guidance. (e.g. FDA, EU, ISO, ISPE, etc.) Experience in a fast-paced environment with the ability to adjust to changing prioritiesDetailed-oriented work standardsSound understanding of Quality Risk Management conceptsRSREMD

Information System Security DeveloperFIST 4573-585CALIBRE Systems Inc., an employee-owned Management Consulting and Digital Transformation Company is seeking a Information System Security Developer (Mid-level) that will design, develop, test, and evaluate information system security throughout the systems development life cycle.The Information System Security Developer’s responsibilities include, but are not limited to, the following:Analyze design constraints, analyze trade-offs and detailed system and security design, and consider life cycle support.Apply security policies to applications that interface with one another, such as Business-to-Business (B2B) applications.Assess the effectiveness of cybersecurity measures utilized by system(s).Assess threats to and vulnerabilities of computer system(s) to develop a security risk profile.Build, test, and modify product prototypes using working models or theoretical models.Conduct Privacy Impact Assessments (PIAs) of the application’s security design for the appropriate security controls, which protect the confidentiality and integrity of Personally Identifiable Information (PII).Design and develop cybersecurity or cybersecurity-enabled products.Design hardware, operating systems, and software applications to adequately address cybersecurity requirements.Design or integrate appropriate data backup capabilities into overall system designs, and ensure that appropriate technical and procedural processes exist for secure system backups and protected storage of backup data.Develop and direct system testing and validation procedures and documentation.Develop detailed security design documentation for component and interface specifications to support system design and development.Develop Disaster Recovery and Continuity of Operations plans for systems under development and ensure testing prior to systems entering a production environment.Develop risk mitigation strategies to resolve vulnerabilities and recommend security changes to system or system components as needed.Develop specific cybersecurity countermeasures and risk mitigation strategies for systems and/or applications.Identify components or elements, allocate security functions to those elements, and describe the relationships between the elements.Identify and direct the remediation of technical problems encountered during testing and implementation of new systems (e.g., identify and find workarounds for communication protocols that are not interoperable).The Information System Security Developer will have demonstrated experience in the following:Designing countermeasures to identified security risks.Designing security controls based on cybersecurity principles and tenets.Designing the integration of hardware and software solutions.Developing and applying security system access controls.Discerning the protection needs (i.e., security controls) of information systems and networks.Evaluating the adequacy of security designs.Conducting audits or reviews of technical systems.Integrating and applying policies that meet system security objectives.The use of design modeling (e.g., unified modeling language).Applying cybersecurity and privacy principles to organizational requirements (relevant to confidentiality, integrity, availability, authentication, non-repudiation).Conducting vulnerability scans and recognizing vulnerabilities in security systems.Desired skills for this position include the ability to:Apply the methods, standards, and approaches for describing, analyzing, and documenting an organization's enterprise information technology (IT) architecture (e.g., Open Group Architecture Framework [TOGAF], Department of Defense Architecture Framework [DoDAF], Federal Enterprise Architecture Framework [FEAF]).Effectively communicate complex information, concepts, or ideas in a confident and well-organized manner through verbal, written, and/or visual means.Effectively collaborate with others as a member of planning teams, coordination groups, and task forces as necessary.US citizenActive Top Secret/Sensitive Compartmented Information (TS/SCI) clearance, eligible for Counterintelligence (CI) Polygraph.IAT, IAM, or IASAE Level 3 certification.Bachelor’s degree or higher from an accredited college or university in Computer Science, Cyber Security, Information Technology, Software Engineering, Information Systems, or Computer Engineering degree; or a degree in a Mathematics or Engineering field.Available for possible travel within the Continental United States (CONUS) and Outside CONUS (OCONUS).St. Louis, Missouri, United StatesFull-Time/RegularEqual Opportunity Employer, including disability/protected veteransPI240049221