good manufacturing practice Jobs

101 - 120 of 1,317 Jobs

Global MES System Engineer - API New FacilitiesJob Title - Global MES System Engineer - API New Facilities

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Lebanon, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Process Engineer (Broadway)Job Title - Process Engineer (Broadway)

Merck KgaACompany Name - Merck KgaA

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St. Louis, Missouri, USA

Full-time

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

Senior Automation EngineerJob Title - Senior Automation Engineer

Regeneron PharmaceuticalCompany Name - Regeneron Pharmaceutical

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Troy, New York, USA

Full-time

Our Automation Engineers keep our cutting-edge process controls and process monitoring systems running at peak efficiency. We provide unsurpassed expertise in designing, developing, implementing, and optimizing Regeneron's sophisticated biopharmaceutical manufacturing processes. As an Automation Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control

Project Management EngineerJob Title - Project Management Engineer

Merck KgaACompany Name - Merck KgaA

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Jaffrey, New Hampshire, USA

Full-time

Project Management Engineer 1Job Title - Project Management Engineer 1

Merck KgaACompany Name - Merck KgaA

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Jaffrey, New Hampshire, USA

Full-time

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Elwood, Kansas, USA

Full-time

Responsibilities: Provide Quality Assurance oversight for the execution, commissioning, qualification, and validation activities for major projects. This may include, but is not limited to; Factory Acceptance Testing, construction oversight, execution of onsite commissioning and qualification activities, support for process validation, etc. Ensure execution of capital projects consider USDA and EMA regulatory and quality requirements. Review relevant documentation including user requirement spec

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Schaumburg, Illinois, USA

Full-time

Responsibilities: Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations). Bachelor's degree or equivalent experience in computer science, information technology, or a related field. High degree of proficiency in Microsoft Office Suite and Smartsheet. Detail-oriented with a strong analytical mindset and problem-solving capabilities. Excellent project

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Indianapolis, Indiana, USA

Full-time

Responsibilities: Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities. Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, and so on. Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activiti

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Carolina, USA

Full-time

Responsibilities: Provide technical input to validation activities. Represent process validation during equipment installations. Support process validation Quality Systems. Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices. Participate in regulatory agency inspections for Process Validation. Serve as one of the main points of contact in communication to customers whose equipment and processes are being validate. Responsible

Metrology TechnicianJob Title - Metrology Technician

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Lebanon, New Hampshire, USA

Full-time

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What we offer you: Leading pay and annual performance bonus for all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Gua

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Johns Creek, Georgia, USA

Full-time

Roles & Responsibilities: Validation Planning: Develop/update Master Validation Plans (MVP) and individual Validation Plans (VP) for system changes. Required: Proven expertise in CSV (Computer System Validation) methodologies (e.g., GAMP5), FDA regulations (21 CFR Part 11, 210, 211, 820 as applicable), and validation of automated manufacturing/control systems. Experience validating PLC-based systems (Beckhoff Twin CAT experience is a significant plus). Responsibilities: Perform tasks under S

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Cincinnati, Ohio, USA

Full-time

Responsibilities: Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP). Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems. Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program. Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, function

Mechanical & Biomedical EngineerJob Title - Mechanical & Biomedical Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Pittsburgh, Pennsylvania, USA

Full-time

Responsibilities: Lead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers. Proactively resolve project

Process Engineer (Equipment Installation & Upgrades)Job Title - Process Engineer (Equipment Installation & Upgrades)

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Lebanon, New Hampshire, USA

Full-time

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, a

Mechanical & Biomedical EngineerJob Title - Mechanical & Biomedical Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Belleville, New Jersey, USA

Full-time

Validation Engineer I - FP PackagingJob Title - Validation Engineer I - FP Packaging

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Clayton, North Carolina, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. 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 and oral treatment supply chains. Our Product Supply

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Allendale, New Jersey, USA

Full-time

Responsibilities: Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously. Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility. Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports. Write reports summarizing results and s

Process and Data Governance ManagerJob Title - Process and Data Governance Manager

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Swiftwater, Pennsylvania, USA

Full-time

Job Description: The Lab Information Management System [LIMS] Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and improvement of the LIMS system. Maintenance support will include supporting Business Administrators in, updating master data for new and existing products, updating master data for new and existing analysis, maintaining system documentation, and providing ad hoc support to other departments. The position is expected t

Validation Engineer IJob Title - Validation Engineer I

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Lebanon, New Hampshire, USA

Full-time

Technician III, Engineering - Process Maintenance (Nights)Job Title - Technician III, Engineering - Process Maintenance (Nights)

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. 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. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f