Gamp jobs in bedford, ma

Marlborough, Massachusetts

•

Today

Key Responsibilities Develop and execute test plans, test cases, and test procedures for industrial automation systems, including PLC logic, HMI screens, SCADA applications, alarms, interlocks, recipes, batch operations, and data acquisition functions Review functional specifications, control narratives, user requirements, I/O lists, sequence of operations, and design documents to define comprehensive test coverage Perform software and system testing, including unit testing, integration testi

Easy Apply

Contract

DOE

Reliability Engineer

Boston, Massachusetts

•

Today

Job Title Reliability Engineer Job Description Summary This individual will provide support for Facility Operations/Engineering department sites as part of the Reliability Engineering team. The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continuous improvement initiatives. This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best Practices for new

Full-time

USD 52.70 - 62.00 per hour

CSV Engineer (Analyst II)

Cambridge, Massachusetts

•

14d ago

About the job: The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing valida

Full-time

Commissioning, Qualification, and Validation (CQV) Engineer

Boston, Massachusetts

•

Today

Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Full-time

Process Technology & Innovation Lead PAT

Lexington, Massachusetts

•

Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Process Technology & Innovation Lead PAT is responsible for defining and driving Takeda's global Process Analytic

Full-time

USD 177,000.00 - 278,080.00 per year

Computer Systems Validation Engineer

Boston, Massachusetts

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

Controls Engineer

Wilmington, Massachusetts

•

Today

We have a Controls Engineering position available in our Wilmington, MA office. This person will support controls engineering project requirements involving PLC programming, DCS programming, HMI/SCADA programming, database management, control panel design, instrumentation specification, engineering documentation support, check-out support and commissioning assistance. Major Responsibilities This position requires the Controls Engineer to conceptualize, detail and implement control systems for

Full-time

CSV Systems Engineer III

Hopkinton, Massachusetts

•

Today

Job Description CSV Systems Engineer in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections. Curia is a g

Full-time

USD 122,800.00 - 145,300.00 per year

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

•

Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

Computer Systems Validation Engineer

Remote

•

Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

•

Today

Job Description Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in

Full-time

USD 96,441.00 - 126,000.00 per year

Platform Information Security Officer (PISO), Life Sciences Platform

Remote

•

Today

Bring more to life. At Danaher, our work saves lives. And each of us plays a part. Fueled by our culture of continuous improvement, we turn ideas into impact - innovating at the speed of life. Our 60,000+ associates work across the globe at more than 15 unique businesses within life sciences, diagnostics, and biotechnology. Are you ready to accelerate your potential and make a real difference? At Danaher, you can build an incredible career at a leading science and technology company, where we

Full-time

USD 225,000.00 - 275,000.00 per year

Senior Automation Engineer

Boston, Massachusetts

•

Today

At E Tech Group, joining our team means joining a group of passionate and forward-thinking experts. We're one of the largest engineering and system integration firms in the United States providing value for our clients through IT automation and control solutions for more than 30 years to the Life Sciences, Mission Critical, Metals & Mining, Warehousing & Distribution, and CPG/Food & Beverage industries. Our national and global scale allows us to help our clients develop and implement standardize

Full-time

Software and Automation Engineer

Bedford, Massachusetts

•

Today

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind

Full-time

USD 94,200.00 - 141,400.00 per year

Director, Global Digital & Technology Systems

Remote

•

Today

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: BeOne Medicines Global Research and Development Technology Solutions (GRDTS) team is seeking a motivated, enthusiastic, and experienced Digital & Technology Systems Direc

Full-time

USD 172,500.00 - 232,500.00 per year

Computer System Validation (CSV) Lead - Oracle Fusion

Boston, Massachusetts

•

23d ago

No OPT/CPT Job Summary We are seeking an experienced Oracle Fusion Computer System Validation (CSV) Lead to support the implementation, validation, and ongoing lifecycle management of Oracle Fusion applications within a regulated life sciences environment. The ideal candidate will have strong experience validating Oracle Fusion Cloud ERP applications, leading risk-based CSV/CSA activities, and ensuring compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity, and applicable GxP requi

Easy Apply

Full-time

55 - 60

SAP Validation

Remote

•

24d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

Easy Apply

Contract

Depends on Experience

CSV Engineer

Woburn, Massachusetts

•

14d ago

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Full-time

Senior Automation Engineer

Remote or New Jersey

•

14d ago

Roles & Responsibilities: Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constr

Full-time

Gamp jobs in Bedford, MA, USA