GAMP jobs in Minneapolis, MN

Remote or Needham, Massachusetts

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12d ago

Title: MES Technical Consultant Regulatory Relevance: GxP The Role: The MES Technical Consultant will serve a key role owning the development and validation of core MES recipe objects and accompanying integrations. Additionally, this individual will also be well versed in Infobatch report development, web development, SQL, ISA S-95 standards will be act as an escalation point contact for the MES, Infobatch and ODH teams for complex initiatives. Key Responsibilities: Lead the design, development,

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Full-time, Third Party

$60 - $70

Software Validation Engineer

Plymouth, Minnesota

•

Today

Roles & Responsibilities: Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good expo

Full-time

Staff Engineer - Software Quality - Indianola, Pa (Hybrid)

Remote or Indianola, Pennsylvania

•

Today

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of br

Full-time

USD 97,264.00 - 145,897.00 per year

Senior CSV Engineer

Remote or Massachusetts

•

Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

CSV and Validation Engineer

Remote or New Jersey

•

Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

•

Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

Sr. IT Program Manager

Remote or Massachusetts

•

Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Uncover a remarkable opportunity at Thermo Fisher Scientific Inc. to push global advancements in health, cleanliness, and safety as a Sr. IT Program Manager in Waltham. Become a part of our elite team, guiding ambitious IT projects that enhance quality, compliance, and supply chain operations within our Contract Development and Manufacturing Organization (CDMO). Argument Development & Case Creation Collaborate

Full-time

Validation Engineer II

Remote or Durham, North Carolina

•

Today

Job Description Summary The Validation Engineer II, assists with the authoring, executing and reviewing of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities:

Full-time

USD 70,000.00 - 130,000.00 per year

Controls Engineer (DeltaV)

Remote

•

Today

Title: Controls Engineer (DeltaV) Location : Remote - but must be in the Kalamazoo, MI area Target Start Date : ASAP Type: Direct Hire Salary : $120-160K (DOE) plus uncapped bonus Our client, a Top 5 systems integrator for automation & controls systems with over 40 years of experience, is seeking an experienced Controls Engineer to design, configure, and implement Emerson DeltaV automation solutions, primarily for life sciences and other process manufacturing industries. This role involves deliv

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Full-time

USD 120,000.00 - 160,000.00 per year

CSA Auditor, TraceLink

Remote

•

11d ago

We are seeking a Computerized System Assurance (CSA) Auditor with deep experience in TraceLink and GxP-regulated environments to ensure the compliance, validation, and lifecycle integrity of computerized systems supporting serialization, traceability, and supply chain management. This role is critical in evaluating vendors, systems, and processes to meet FDA, EMA, and global regulatory expectations for data integrity and system validation. Key Responsibilities: Plan, conduct, and report CSA aud

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Contract

85 - 90

Computer System Assurance

Remote

•

26d ago

Location Remote (USA) Must Have Skills: Proven experience in CSA and GAMP 5 implementation.RTM configuration in any ALM tool, exposure to the Veeva CMS tools, need to have CSM admin experience.Strong knowledge of Veeva validation management and a basic understanding of Veeva configurations.Excellent analytical and problem-solving skills.Strong verbal and written communication abilities.Demonstrated ability to work effectively with global, virtual teams.Experience working independently, guiding

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Contract

$45+

Director - Lab Informatics

Remote

•

Yesterday

Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increase operational efficiency, and ensure regulatory complianc

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Contract, Third Party

Director, Lab Informatics

Remote

•

Yesterday

Director, Lab Informatics Job Location- Remote Long Term Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, incre

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Full-time, Part-time, Third Party, Contract

Laboratory Information Management System (LIMS) Director

Remote

•

2d ago

Role: Lab Informatics Location- Remote Duration: 12+ Month Position Summary: The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development, quality control (QC), and manufacturing science and technology (MSAT). The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity, increa

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Third Party, Contract

Depends on Experience

Licensed Boiler & Utilities Engineer

Lauderdale, Minnesota

•

Today

High-pressure role, high rewards - Chief B or 1st Class B needed! This Jobot Job is hosted by: Kal Mayer Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $35 - $50 per hour A bit about us: We're a high-performance production facility operating in the heart of St. Paul, MN. With a strong commitment to quality and safety, our team works around the clock to ensure reliable operations and exceptional results. Our workplace culture emphasizes col

Full-time

USD 35.00 - 50.00 per hour

Plant Engineering Director (Remote) - Minnesota

Remote or Minneapolis, Minnesota

•

Today

Dairy Farmers of America (DFA), Dairy Brands a dairy marketing cooperative owned by more than 12,500 family farmers. Our mark matters and it represents the wholesomeness of dairy that we share with our communities and loved ones. DFA manufactures a variety of dairy products, including cheese, butter, fluid milk, ice cream, dairy ingredients and more, under well-known and established regional brands. Our fingerprints touch thousands of brands across the marketplace, and we're passionate about del

Full-time

USD 165,000.00 - 195,000.00 per year

Senior Supplier Engineer

Remote or Arden Hills, Minnesota

•

Today

Additional Location(s): US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing -

Full-time

USD 82,600.00 per year

Process Engineer - Senior Level - Pharmaceutical and Life Sciences Focus (Hybrid)

Remote or Minneapolis, Minnesota

•

Today

The role - what you'll do Barr is seeking a senior process engineer with demonstrated consulting experience to join our multi-disciplinary project teams serving manufacturing clients in the pharmaceutical and life sciences sector. The person in this position will play a key role in advancing our pharmaceutical services with new and existing clients by providing process engineering and technical expertise. This person will have opportunities to grow in project leadership and collaborate with mult

Full-time

USD 115,000.00 - 130,000.00 per year

Sr. Supplier Engineer

Remote or Minnetonka, Minnesota

•

Today

Additional Location(s): US-MN-Arden Hills; US-MN-Minnetonka Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supporte

Full-time

USD 82,600.00 per year

Business Analyst w/ PBI & SQL

Saint Paul, Minnesota

•

Today

Description We are looking for a talented Business Analyst to join our team. This position requires someone with strong technical skills and the ability to bridge the gap between business processes and technical solutions. The ideal candidate will leverage their expertise in SQL, Power BI, and data analysis to validate and support system changes while developing impactful data models and reports. Responsibilities: Collaborate with stakeholders across all levels to gather and analyze application

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Full-time

USD 50.00 - 60.00 per hour

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GAMP jobs in Minneapolis, MN, USA