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Danvers, Massachusetts

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Today

Responsibilities: Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with pro

Full-time

Validation Engineer, Sterile & Cleaning

Bedford, Massachusetts

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Today

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute

Full-time

Process Validation Engineer

Danvers, Massachusetts

•

Today

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

Full-time

Validation Support Engineer

Boston, Massachusetts

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Today

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

Full-time

Validation Engineer

Raynham, Massachusetts

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Today

Responsibilities: Ask candidates if they have validated equipment and what type of equipment they have validated. Mechanical/manufacturing experience. Writing and executing validation protocols. CSV is nice to have, but if the candidate has done that exclusively it will not work. Requirements: A minimum of a Bachelor's degree in Engineering is required. Minimum of 1-3 years' experience in medical device manufacturing, Bio/pharma is also good Develop and implement processes to support the

Full-time

Supplier Project Engineer

Acton, Massachusetts

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Today

RESPONSIBILITIES: Kforce has a client in Acton, MA that is seeking a Supplier Project Engineer with experience in FDA-regulated industries and strong skills in Minitab or JMP. This role is ideal for someone with a quality-focused mindset and a background in mechanical/automation or process/data analysis. Key Responsibilities: * Lead supplier capital qualifications from kickoff through production * Oversee validation/qualification protocols and reporting * Manage equipment procurement and instal

Contract

$50 - $60 hourly

Sr. Equipment Engineer - 2nd Shift

Danvers, Massachusetts

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Today

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

Full-time

USD 105,000.00 - 169,050.00 per year

Principal Validation Engineer

Danvers, Massachusetts

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Today

Full-time

Sr. Design Quality Engineer

Newton, Massachusetts

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Today

Location: Newton, MA Salary: $70.00 USD Hourly - $100.00 USD Hourly Description: Job Title: Principal Quality Engineer Location: MA Duration:- 12 + Months Responsibilities: Represent the Quality Department as a subject matter expert in Incoming Inspection/Supplier Quality within a cross-functional team for new product development of medical devices. Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of components/material/products

Full-time

Compensation information provided in the description

Supplier Project Engineer

Remote

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7d ago

Education and Experience: 3 years of relevant experienceBS Engineering Degree (Plastics, Mechanical, Manufacturing/Industrial) or related fieldPreferred Skills and Competencies: Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for component manufacturing processes and secondary Job Description Summary operations: Strong written and verbal communication skills Possess strong analytical and problem-solving skills Familiari

Easy Apply

Contract

Depends on Experience

Principal Quality Engineer

Newton, Massachusetts

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Today

Location: Newton, MA Salary: $90.00 USD Hourly - $100.00 USD Hourly Description: Our client is currently seeking a Principal Quality Engineer for a 6 month + contract. Job Title: Principal Quality Engineer, Contractor Location: Endovascular Robotics business within Advanced Therapies Employment Type: Full-time Shift: 1st shift; 9-5, flexible for core hours (10-4) Screening: Background and drug screening required About Us: We are a global technology leader in robotic-assisted vascular

Full-time

Compensation information provided in the description

Supplier Engineer II

Remote or Danvers, Massachusetts

•

Today

Full-time

USD 91,800.00 - 124,200.00 per year

Sr. Associate, IT Systems Administrator

Billerica, Massachusetts

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Today

Software Guidance & Assistance, Inc., (SGA), is searching for a Sr. Associate, IT Systems Administrator for a FULL TIME assignment with one of our premier Pharmaceutical clients in Billerica, MA. The Sr. Associate, IT Systems Administrator will manage day-to-day System Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab Manufacturing and other regulatory operations including, but not limited to, networked and non-networked standalone instruments

Full-time

USD 130,000.00 - 130,000.00 per year

Verification and Validation R&D Engineer

Marlborough, Massachusetts

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Today

Responsibilities: Designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment. Prepares test and diagnostic plans/programs and infrastructure, designs test fixtures and equipment, and completes specifications and procedures for new products. Plans the labor, schedules, and equipment required for testing and evaluating standard and special devices. Lead and execute Verification and Validation (V&V) activities for disposable kit development. De

Full-time

Senior Engineer, Design Transfer Specialist

Remote or Cambridge, Massachusetts

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Today

Career Category Operations 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 each

Full-time

USD 119,195.00 per year

Computer System Validation Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V

Full-time

DeltaV Automation Engineer - Pharmaceuticals

Remote

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16d ago

Piper Companies is hiring a DeltaV Automation Engineer for a growing BioPharma company located in Holly Springs, NC. The DeltaV Automation Engineer will be responsible for designing, developing, and maintaining automation systems for pharmaceutical manufacturing processes. This role requires expertise in Emerson DeltaV DCS (Distributed Control System), with a focus on process optimization, validation, and compliance with industry regulations. The DeltaV Automation Engineer can work remote, but w

Full-time

USD 140,000.00 - 170,000.00 per year

Manufacturing Execution Systems (MES) Engineer

Remote

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2d ago

About the Role: We are seeking a skilled MES Engineer to join our team, where you ll work closely with the Global IT organization and site stakeholders to understand and address critical business needs in Pharmaceutical/Biotech manufacturing environments. You ll play a key role in designing, implementing, validating, and supporting cutting-edge MES (Manufacturing Execution System) solutions, ensuring systems remain compliant and deliver meaningful value to operations. Key Responsibilities: Colla

Easy Apply

Contract, Third Party

Depends on Experience

Validation Lead, SAP S4 HANA

Remote or New Jersey

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Today

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati

Full-time

Engineer III, Validation

Remote or Fair Lawn, New Jersey

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Full-time

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