Manufacturing/Mechanical Salary in New Brunswick, NJ

Innova Solutions is immediately hiring for an QUALITY MANAGERTittle - QUALITY MANAGER Duration -12 Months Location - New Brunswick, NJ (onsite) Pay Range*: $45.23- $46.20 per hour. As a(n) QUALITY MANAGER you will: Job Description: Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all and applicable Food and Drug Administration (FDA) and international regulatory standards. Responsibility to ensure that released products comply with internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls). Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP's), authoring and executing Risk Mitigation Plans as needed Determines disposition of drug products according and regulatory specifications and standards Review change requests generated internally or by External Manufacturer Reviews Annual Product Quality Reviews (APQR's) authored by Contract Manufacturers/Packagers and supplement APQR's as required Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action Review Quality Agreements Review and approve product quality complaint investigations Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements Write, review and implement SOP's to ensure compliance with current standard and current Good Manufacturing Practices (cGMP) Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM) Supports product recalls and executes plan as assigned Represent during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements Assist with preparation of audit observations Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate and FDA and European Medicines Agency (EMA) cGMP regulations and policies Represent Quality on cross-functional teams within the \"Virtual Manufacturing Plant\", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams The ideal candidate will have: B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent Minimum of five (5) years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience Experience in a Quality Assurance, Quality Control or equivalent function is required Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired Knowledge in solid dosage forms, parenteral technology, biologics or combination products Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA). 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! Aritra Roy 4702230481 [email protected] PAY RANGE AND BENEFITS: Pay Range*: $45.23- $46.20 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. 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

Facilities Validation Engineer No C2C or sponsorshipThe Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. Job Function: Prepare and execute IQ / OQ / PQ protocols and write summary reports for production/packaging equipment, utilities (Temperature mapping study, Stability Chamber , HVAC, Air compressor, Boiler, Purified water system) and process area etc.,Ensure that assigned validation activities are performed timely and in line with the current requirements and cGMP. Prepare and train for the Set up / Operational / Cleaning / Maintenance SOPs Identify, investigate and troubleshoot deviations for multiple concurrent projects Preparation of Personnel flow, Incoming and Finished material flow, as well as Waste flow in the facility Assist in preparation of internal audit, FDA, DEA and other agency audit responses. Prepare, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents. Manufacturing / Production environment Environmental related to manufacturing/production environments: Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing. Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction. Odors: Unpleasant smells. Gases: Examples include carbon monoxide and ozone. Dust: Airborne particles of any kind, such as textile dust, wood, and silica. Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock. Education and Experience Minimum of five (5) years in Pharmaceutical, preferably Oral Solid Dosage. Bachelor's Degree in Engineering or Science related field. Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that supports production operations as well as research and development. Good understanding of cGMPs and good documentation practices in order to prepare system life cycle technical documents such as URS, FRS,VMP, protocol generation and execution to support FAT, SAT, commissioning, qualification (IQ, OQ), SOPs, Validation (PQ, DS, CV, PV), FMEA and Validation Master Plan. Technical knowledge to write, prepare and execute the Change Controls, Investigations, SOPs, protocols, final summary reports and validation documents. Demonstrated excellent communication: verbal, written and presentation skills. A self-starter with a hands-on approach and a can-do attitude. A team building champion driving innovative cross functional synergies. Excellent project management and problem solving skill The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Sr Manager Manufacturing Engineering and MaintenancePharmaceutical Company Oral Solid Dosage experienceThe Director is responsible for providing direction and leadership to the engineering supervisors which execute all Engineering related activities carried out on-site (automation, capital projects, utilities, equipment, etc.). Directly responsible for maintenance of utilities in the pharmaceutical manufacturing site. Responsible for the management of internal company assets, departmental personnel, external professional Engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects.Support production volume.Maintenance - Execute with the help of supervisors and mechanics, the planned and unplanned maintenance activities for all utilities equipment like HVACs, boilers, compressed air, chiller etc.PM module - Monitor and work order status, follow up to close open work orders in timely manner.Ensures timely PM and break down work order execution. Ensures work orders are closed and returned back to the maintenance planning group. Ensures routine PM is completed as specified.Review and provide recommendations to improve PM work to reduce down time.Maintain manufacturing and pkg. machines to perform at optimum performance level to meet production targetsUtilities - Maintain HVAC Systems, USP Water, Boilers, Compressed Air, Hot Water and Electricity available in quality and quantity to meet production targets. Includes all safety and security systems.Facility - Maintain facilities all the time to acceptable level of FDA, OSHA and environmental agency compliance.Maintenance Budget - Support preparation for annual maintenance budget. Forecast major activities and approximate expenses.Review and monitoring the monthly expenses, try to contain expenses within budgets, without affecting quality and output.Coordinates major shut downs with manufacturing and project. Coordinates utility, fire and security systems shut downs with Project management.Evaluate and plan maintenance work force with the help of supervisors to meet production requirementsCapital Projects - Support planned activities from annual budgets $10,000 up to $ 1Mn. Prepare capital project proposals in line with the requirements, implementation and timely completion. Follow company policy for execution. Provide engineering support for evaluation of new machines.Compliance -Maintain Engineering Documentation up to date to the requirements of FDA, EU, OSHA, Environmental, Local Township, Insurance Carrier, and NFPA.Review, renew and update SOP's.Provide support to create, close CCR, Investigations in Trackwise appropriately and in timely manner.Prepares site for any audits. Implements audit report recommendationsNew Product Launches - Coordinate and provide appropriate support to Product Development and Production to launch products in time.Organizes training and development programs for supervisors, team leads and mechanical staff.Works with Maintenance planning on best practices for work order and spare parts systems.Coordinates emergency services at site.This is supervisory position with direct reports; therefore, this position will establish goals and objectives, prepare performance appraisals, monitor/review work product and coach/mentor direct reports.Education and Job QualificationBachelor's Degree in Mech./Electrical Engineering preferredDemonstrated excellent communication: verbal, written and presentation skills.A self-starter with a hands-on approach and a can-do attitude.A team building champion driving innovative cross functional synergies.Excellent project management and problem solving skillMinimum of Ten (8-10) years in Pharmaceutical, Oral Solid Dosage manufacturing companyReports to VP Operations.

For More Information:TextEuropastryto(631) 857-4886 Do you want to join a growing company with a proven track record for success and growth? Europastry is a family business founded in Barcelona in 1987 by Pere Galles with locations worldwide! The bakery business is our passion and this is your opportunity to be a member of our team. We are searching for a motivated & experienced Production Supervisor. The Production Supervisor coordinates and supervises activities of workers that assemble dough products to mass produce bread and sheeted items by performing the following duties. JOB SUMMARY & DUTIES INCLUDE: Studies the production schedule and prepares a plan for each line for labor and machining.Supervises workers engaged in molding, shaping and manipulating dough into specific shapes or sizes.Rotates workers at different intervals to maintain uniformity to workers.Assigns tasks according to work schedules and assigns breaks and lunch periods.Must be able to meet or surpass the set quota for all high labor bread items as set by the company.Must know all emergency stops on all lines.Records freezer temperatures at different intervals in conformance to specifications.Removes samples at different intervals for quality control inspection.Visually inspects product for open seams and places downward in preparation for entry into freezer.Identifies any inconsistencies and addresses them with the line operator to fix the problem.Suggests changes in the production schedule to increase the production throughput.Analyzes and resolves work problems, or assists workers in solving work problems.Trains and leads new employees on the production line according to company specifications.Identify ways to motivate workers to achieve work goals.Alerts Production Shift Manager of complications and situations that may arise.Maintains time and production records and daily activity reports..Reports on downtime and scrap accumulation and ensures the correct disposition of scrap.Must be familiar with the end of run marker procedure and be able to coordinate the change of product markers along with the paperwork.Ensures machines are adjusted as needed for production.Assists machine operators in replacing metal plates as job changes occur.Fills automatic dispensers with ingredients or spices to ensure the even distribution of ingredients as product moves along line.Must be able to separate product and place in line formation.Identify and reports any machine malfunctions.Lead, mentor and supervise others to generate expected results.Reviews safety issues with Shift Assistant Manager and Director of Manufacturing.Interfaces with Quality Control to maintain product quality standards.Reviews and interprets established production KPIs (Key performance indicators) with the Production Superintendent and Director of Manufacturing in relation to any scrap and waste for each individual line. Writes analyses and reviews of employees they supervise.Participates in special projects and performs other duties as required. QUALIFICATIONS & EDUCATION: Minimum of High school diploma or general education degree (GED) and 3-5 years Supervisor experience in a manufacturing environment. Food Manufacturing experience a plus. Must possess strong verbal and written communication skills. He/she must be able to identify and analyze constraint processes and implement solutions. Must be bi-lingual. What can Europastry offer to you? Competitive compensation package including: Medical, Dental, Vision, Life Insurance & ADD, STD, LTD, 401K, FSA, and Paid Time OffOngoing opportunities for development and career advancementExciting fast-paced entrepreneurial environment.Free Employee Bread ProgramEarned Wage Access Benefit #EuroHigh

For More Information:TextEuropastryto(631) 857-4886 Do you want to join a growing company with a proven track record for success and growth? Europastry is a family business founded in Barcelona in 1987 by Pere Galles with locations worldwide! The bakery business is our passion and this is your opportunity to be a member of our team. We are searching for a motivated & experienced Production Supervisor. The Production Supervisor coordinates and supervises activities of workers that assemble dough products to mass produce bread and sheeted items by performing the following duties. JOB SUMMARY & DUTIES INCLUDE: Studies the production schedule and prepares a plan for each line for labor and machining.Supervises workers engaged in molding, shaping and manipulating dough into specific shapes or sizes.Rotates workers at different intervals to maintain uniformity to workers.Assigns tasks according to work schedules and assigns breaks and lunch periods.Must be able to meet or surpass the set quota for all high labor bread items as set by the company.Must know all emergency stops on all lines.Records freezer temperatures at different intervals in conformance to specifications.Removes samples at different intervals for quality control inspection.Visually inspects product for open seams and places downward in preparation for entry into freezer.Identifies any inconsistencies and addresses them with the line operator to fix the problem.Suggests changes in the production schedule to increase the production throughput.Analyzes and resolves work problems, or assists workers in solving work problems.Trains and leads new employees on the production line according to company specifications.Identify ways to motivate workers to achieve work goals.Alerts Production Shift Manager of complications and situations that may arise.Maintains time and production records and daily activity reports..Reports on downtime and scrap accumulation and ensures the correct disposition of scrap.Must be familiar with the end of run marker procedure and be able to coordinate the change of product markers along with the paperwork.Ensures machines are adjusted as needed for production.Assists machine operators in replacing metal plates as job changes occur.Fills automatic dispensers with ingredients or spices to ensure the even distribution of ingredients as product moves along line.Must be able to separate product and place in line formation.Identify and reports any machine malfunctions.Lead, mentor and supervise others to generate expected results.Reviews safety issues with Shift Assistant Manager and Director of Manufacturing.Interfaces with Quality Control to maintain product quality standards.Reviews and interprets established production KPIs (Key performance indicators) with the Production Superintendent and Director of Manufacturing in relation to any scrap and waste for each individual line. Writes analyses and reviews of employees they supervise.Participates in special projects and performs other duties as required. QUALIFICATIONS & EDUCATION: Minimum of High school diploma or general education degree (GED) and 3-5 years Supervisor experience in a manufacturing environment. Food Manufacturing experience a plus. Must possess strong verbal and written communication skills. He/she must be able to identify and analyze constraint processes and implement solutions. Must be bi-lingual. What can Europastry offer to you? Competitive compensation package including: Medical, Dental, Vision, Life Insurance & ADD, STD, LTD, 401K, FSA, and Paid Time OffOngoing opportunities for development and career advancementExciting fast-paced entrepreneurial environment.Free Employee Bread ProgramEarned Wage Access Benefit #EuroHigh