gmp Jobs in jersey city, nj

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CSV Engineer

Katalyst Healthcares and Lifesciences

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Nutley, New Jersey, USA

Full-time

Job Description: Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team. Responsibilities:
Posted 60+ days ago | Updated 9 hours ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 60+ days ago | Updated 9 hours ago

Raw Materials Technical Specialist

Aditi Consulting

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Remote or Cambridge, Massachusetts, USA

Contract

Payrate: $38.00 - $40.00/hr. Summary: The ideal candidate will have a strong background in documentation and regulatory specification development within a GMP-compliant environment. They should bring experience in project management and raw material specification, ideally from pharmaceutical, biotech, or similarly regulated industries (such as aerospace or chemical engineering). The role is fully remote and requires someone who can work independently with minimal supervision while contributing t
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Posted 12 days ago | Updated 3 hours ago

Senior Engineer, Pharmaceutical Operations Engineering

Merck & Company Inc

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Rahway, New Jersey, USA

Full-time

Job Description This Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)
Posted 10 days ago | Updated 9 hours ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 50 days ago | Updated 9 hours ago

Engineer II, Field Service

Thermo Fisher Scientific

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Pearl River, New York, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions Job Description Engineer II, Field Service Location: Pearl River, NY - Pfizer Job Description: When you join us at Thermo Fisher Scientific, you'll be part of a
Posted 60+ days ago | Updated 9 hours ago

Process Development Engineer II - Synthetic and Bioconjugation Scale-Up

Regeneron Pharmaceutical

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Tarrytown, New York, USA

Full-time

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic Process Development Engineer II for its new Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will develop conjugation and purification processes for bioconjugation of proteins to a diverse range of small-molecules. You would work in close collaboration with cross-functional teams for process development and optimiza
Posted 60+ days ago | Updated 9 hours ago

GIE PPD Staff Engineer I Molding

Becton Dickinson & Company

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Franklin Lakes, New Jersey, USA

Full-time

Job Description Summary The molding Engineer is leading and coordinating the process development activity to support new product development projects from the innovation phase to the first commercial batches. In this role the molding engineer will influence product and process design & ensure manufacturability of products. The target being to develop superior product design efficient manufacturing process for highest quality and lowest cost. Job Description We are the makers of possible BD is
Posted 60+ days ago | Updated 9 hours ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.
Posted 60+ days ago | Updated 9 hours ago

Field Service Engineer I (lab equipment)

Thermo Fisher Scientific

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Colorado, USA

Full-time

Work Schedule Other Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Field Service Engineer (lab equipment) When you join us at Thermo Fisher Scientific, you'll be part of an inquis
Posted 22 days ago | Updated 1 day ago

Staff Software Engineer, Manufacturing Engineering

Thermo Fisher Scientific

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Remote or Atlanta, Georgia, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description About Us: At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. We are revolutionizing the manufacturing industry with brand new technology and innovative solutio
Posted 10 days ago | Updated 9 hours ago

Sr Technical Operations Training & Support Specialist

Thermo Fisher Scientific

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Remote or Greenville, North Carolina, USA

Full-time

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Sr Technical training and support engineer and have the unique opportunity to build, grow, and share your expertise in the manuf
Posted 39 days ago | Updated 9 hours ago

Technical Operations Training & Support Specialist

Thermo Fisher Scientific

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Remote or Greenville, North Carolina, USA

Full-time

Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Position Summary: Join Thermo Fisher Scientific Inc. as a Technical training and support engineer and have th
Posted 40 days ago | Updated 9 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 20 days ago | Updated 9 hours ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 9 days ago | Updated 4 days ago

Mechanical Engineer II

Fresenius Medical Care

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Remote or Lawrence, Massachusetts, USA

Full-time

PURPOSE AND SCOPE: The Mechanical Engineer II will play a key role in improving our Home HD products and our patients' lives. This individual will apply sound engineering principles in the support of our current product portfolio and will be involved in different parts of a product's life, including but not limited to the feasibility evaluation for new features and products to improve the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for suppo
Posted 29 days ago | Updated 9 hours ago

Bioinformatics Software Architect

Thermo Fisher Scientific

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Indiana, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies
Posted 7 days ago | Updated 9 hours ago

Principal Engineer - Thermal Engineering

Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea
Posted 60+ days ago | Updated 9 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 28 days ago | Updated 9 hours ago

Staff Engineer II, Firmware (Hybrid)

Becton Dickinson & Company

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Remote or Milpitas, California, USA

Full-time

Job Description Summary Seeking an experienced staff level Firmware Development Engineer to play a leading role in developing high quality instrument control firmware for BD's line of flow cytometers. As a leading member of the firmware development team, you will be responsible for architecting, developing, debugging, and documenting robust and reliable firmware to satisfy the product requirements. Must be detail-oriented, process-focused, and results-driven. Are you ready to make a difference
Posted 60+ days ago | Updated 9 hours ago