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Process Engineer I - Active Pharmaceutical Ingredients

Novo Nordisk Inc

•

Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable an
Posted 17 days ago | Updated 2 hours ago

IBM Maximo EAM Techno-Functional SME

Skywaves MP LLC

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Pittsburgh, Pennsylvania, USA

Full-time

This is a C2C opportunity We are seeking an experienced IBM Maximo EAM Techno-Functional SME with deep expertise in the Life Sciences industry. This role will support Thermo Fisher Scientific s enterprise asset management needs and requires an individual who can contribute immediately without training or onboarding. Please note: Experience in Maximo for non-life science domains (e.g., automotive, oil & gas, utilities, transportation) is not relevant to this position. Key Responsibilities:Provide
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Posted 20 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 1 day ago | Updated 2 hours ago

Commissioning & Qualification (C&Q) Project Engineer | Indianapolis, IN |Onsite

Stellent IT LLC

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Indianapolis, Indiana, USA

Full-time, Contract, Third Party

Title: Commissioning & Qualification (C&Q) Project Engineer Location: Indianapolis, IN |Onsite Duration: 12+ months Role Overview: We are seeking a detail-oriented and proactive C&Q Project Engineer to support commissioning and qualification activities for equipment and systems in an API manufacturing facility. This role is ideal for candidates with technical expertise in facility, utilities, and API manufacturing process systems who excel in documentation, data analysis, and cross-functional
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Posted 5 days ago | Updated 3 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 2 days ago | Updated 2 hours ago

IT infrastructure CSV Consultant

Katalyst Healthcares and Lifesciences

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Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting
Posted 48 days ago | Updated 2 hours ago

Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

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Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl
Posted 48 days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and
Posted 48 days ago | Updated 2 hours ago

Process Validation Engineer

Katalyst Healthcares and Lifesciences

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Albany, Georgia, USA

Full-time

Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology transfers. Lead comprehensive IQ/OQ/PQ validation activities across multiple projects. Create robust standard operating procedures for manufacturing excellence. Ensure continuous process verification for robust manufacturing operations. Coordinate cross-fu
Posted 48 days ago | Updated 2 hours ago

Senior Engineer

Amgen Inc

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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 3 days ago | Updated 2 hours ago

Associate Process Engineer - API (12 hour day shift)

Novo Nordisk Inc

•

Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable an
Posted 3 days ago | Updated 2 hours ago

Associate Process Engineer - API (12 hour night shift)

Novo Nordisk Inc

•

Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable an
Posted 3 days ago | Updated 2 hours ago

Technical Manager-DeltaV Batch DCS

Multivision Inc-IL

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Indianapolis, Indiana, USA

Contract, Third Party

Job Title: Technical Manager Location: Indiana, IN (Hybrid) Role: Contract Duration: 2+ Years Job Summary: The Program Technical Office (PTO) will develop the automation philosophy and technical standards for the program and ensure consistency throughout the projects. During the project execution stage of the projects the PTO will support and provide oversight to the individual project teams. The PTO technical manager will be accountable for the management of PTO deliverables and contribute tech
Easy Apply
Posted 26 days ago

CQV Engineer

Zachary Piper Solutions, LLC

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Pittsburgh, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a highly skilled and motivated CQV Engineer to join our team in Pittsburgh, PA, supporting a greenfield biologics manufacturing facility. This role is ideal for professionals with a strong background in Commissioning, Qualification, and Validation (CQV) within the biopharmaceutical industry, particularly those with hands-on experience in greenfield site start-ups. Responsibilities for the CQV Engineer: Lead and execute CQV activities for facility, utility, a
Posted 25 days ago | Updated 15 days ago

Upstream Manufacturing Associate

Zachary Piper Solutions, LLC

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Washington, District of Columbia, USA

Full-time

Upstream Manufacturing Associate - Clinical Production Piper Health and Sciences is seeking an Upstream Manufacturing Associate to support clinical production in a cGMP biopharmaceutical environment. This role offers hands-on experience in bioprocessing and cell culture, helping advance therapies into clinical trials. Ideal for candidates looking to grow in biotech manufacturing . Responsibilities for Upstream Manufacturing Associate Include: Operate upstream biomanufacturing equipment: biorea
Posted 33 days ago | Updated 15 days ago

Quality Control Manager

Zachary Piper Solutions, LLC

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Wayne, Pennsylvania, USA

Full-time

Piper Companies is seeking a Quality Control Manager to join a reputable Biologics Quality Control Testing company located in Wayne, Pa. Responsibilities of the Quality Control Manager include: Lead projects, collaborate with clients and teams, and ensure expectations are met Oversee testing, manage deviations, and ensure adherence to global regulations Represent the team in audits, address issues, and implement corrective actions Manage assay development, validation, and ongoing compliance
Posted 33 days ago | Updated 15 days ago

Validation Engineer

Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functi
Posted 48 days ago | Updated 2 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functional
Posted 48 days ago | Updated 2 hours ago

Senior MES Engineer

PARAKEET WORLD SOLUTIONS LLC

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Raleigh, North Carolina, USA

Full-time

Position: Senior MES Engineer Location: Raleigh, NC Job Type: On site Education level: Bachelor s degree JOB DESCRIPTION:Design, develop, and implement MES solutions, acting as the project lead or team lead.Interact with clients to gather requirements and deliver high-quality MES systems.Oversee all project phases from concept to commissioning, ensuring alignment with Life Sciences regulations (GMP, 21 CFR Part 11, etc.).Lead project teams, manage budgets, and ensure timely delivery.Integrate
Easy Apply
Posted 4 days ago

Automation Engineer

Katalyst Healthcares and Lifesciences

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Framingham, Massachusetts, USA

Full-time

Roles & Responsibilities: Lead design, configuration, and commissioning of DeltaV and Client-X automation systems for GMP-critical manufacturing equipment and process controls. Support change controls, deviations, and CAPAs involving DeltaV and Client-X logic, batch strategies, and alarm configuration in collaboration with QA and Validation. Develop and modify control modules, phases, and equipment modules within DeltaV in alignment with S88 batch architecture standards. Provide hands-on trouble
Posted 23 days ago | Updated 2 hours ago