good manufacturing practice Jobs

121 - 140 of 1,113 Jobs

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Fall River, Massachusetts, USA

Full-time

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams t

EngineerJob Title - Engineer

ACL DigitalCompany Name - ACL Digital

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Thousand Oaks, California, USA

Full-time

Fully onsite - Monday - Friday Ideal candidate: B.S. 2 YOE. Nice to have: Tech transfer experience Ideal candidate: The ideal candidate for this role should have a bachelor's degree in any engineering discipline, though candidates with a fresh master's degree are also suitable if they bring strong soft skills. They should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug pr

Technician III, Engineering - Process (Weekend AM)Job Title - Technician III, Engineering - Process (Weekend AM)

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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plainsboro Township, New Jersey, USA

Full-time

Job Description: Qualified candidates must be experienced in one or more of the following areas of validation: Equipment Qualification Process Qualification The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with

LIMS Master Data SpecialistJob Title - LIMS Master Data Specialist

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Position Summary: Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement. Responsibilities: Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers. Provide electronic systems operational support and troubleshooting to end use

Senior EngineerJob Title - Senior Engineer

Amgen IncCompany Name - 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

Systems Administrator / Technical Lead - Process Control SystemsJob Title - Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Foster City, California, USA

Full-time

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates

Senior/Principal Engineer Visual Inspection - ParenteralJob Title - Senior/Principal Engineer Visual Inspection - Parenteral

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Indianapolis, 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

Senior Automation EngineerJob Title - Senior Automation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

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: As a Senior Automation Engineer, you will work in a hybrid position and be part of the Automation engineering group

Senior Development Engineer - Plastic ProductsJob Title - Senior Development Engineer - Plastic Products

Merck KgaACompany Name - Merck KgaA

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Bedford, Massachusetts, USA

Full-time

Work Location: Bedford, Massachusetts Shift: No Department: LS-PS-RUB1 Single Use Products 1 Recruiter: Troy Bradley This information is for internals only. Please do not share outside of the organization. Your Role We are currently seeking a Senior Development Engineer: Plastic Product Design for a role within the Single Use and Integrated Systems R&D group at MilliporeSigma Process Solutions business unit. In this position, the individual will be responsible for developing innovative plasti

Staff Engineer, ModelingJob Title - Staff Engineer, Modeling

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Boston, Massachusetts, USA

Full-time

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 OBJECTIVE: Synthetic Molecule Process Development (SMPD) is responsible for the development of robust and cost-effective processes f

CSV EngineerJob Title - CSV Engineer

Sanofi U.S.Company Name - Sanofi U.S.

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Swiftwater, Pennsylvania, USA

Full-time

Job Title: CSV Engineer Location: Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/ Overview Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improv

Senior Engineer, ProjectsJob Title - Senior Engineer, Projects

Amgen IncCompany Name - Amgen Inc

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Holly Springs, North Carolina, USA

Full-time

Senior Director, Parenteral Process Engineering, Engineering Technology CenterJob Title - Senior Director, Parenteral Process Engineering, Engineering Technology Center

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

Team Lead, Engineering MaintenanceJob Title - Team Lead, Engineering Maintenance

NovartisCompany Name - Novartis

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Indianapolis, Indiana, USA

Full-time

Job Description Summary At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Team Lead, Engineering Maintenance manages a team of Maintenance technicians to support manufacturing continuously, efficiently, and effectively through maintenance activ

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end

Associate Director - Digital Engineering SolutionsJob Title - Associate Director - Digital Engineering Solutions

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

Automation Engineer IIIJob Title - Automation Engineer III

Sanofi U.S.Company Name - Sanofi U.S.

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Framingham, Massachusetts, USA

Full-time

Job Title: Automation Engineer Location: Framingham, MA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The MA Bio-Campus is home to Sanofi's digital facility which won ISPE's Facility of the Future and Facility of the Year