Good manufacturing practice Jobs

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Validation Engineer

ACL Digital

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 equipme

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Vacaville, California, USA

Full-time

Responsibilities: Supervisor Principal Validation Engineer. Responsible for defining qualification / validation strategies and coordinating testing activities required to complete assigned projects in support of continued cGMP operations at the Polaris Vacaville commercial manufacturing facility. This consists of initial qualification, requalification, periodic review and Validation activities associated with capital/expense projects. Performance of such validation activities includes equipment

Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and Lifesciences

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

CQV Engineer

Katalyst Healthcares and Lifesciences

Rocky Mount, North Carolina, USA

Full-time

Responsibilities: Lead CQV activities for new and modified filling lines, including isolator systems. Develop and execute IQ, OQ, and PQ protocols for filling equipment such as vial washers, dehydrogenation tunnels, filling machines, and capping systems. Perform risk assessments (e.g., FMEA) for filling line modifications and qualifications. Troubleshoot and resolve technical issues during qualification activities Clean Utility System. Manage CQV processes for clean utility systems, including pu

Technician III, Engineering - Process (Weekend AM)

Novo Nordisk Inc

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

Engineer - Process Control - Peptides Nano Filtration

Eli Lilly and Company

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

Staff Engineer, Facilities

Johnson & Johnson

Jacksonville, Florida, USA

Full-time

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

MES System Engineer

Eli Lilly and Company

Pleasant Prairie, Wisconsin, 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 DEVELOPMENT ENGINEER III

Becton Dickinson & Company

Tempe, Arizona, USA

Full-time

Job Description Summary This position actively participates as a key cross-functional team member on new product development projects with a focus on design for manufacturability and the design, development, implementation and validation of manufacturing processes, test methods and equipment. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the

IDAP MES System Engineer Tech@Lilly

Eli Lilly and Company

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

Supply Chain Business Analyst- SAP ERP

TSR Consulting Services, Inc.

Summit, New Jersey, USA

Contract

Our client, a leading pharmaceutical company, is hiring a Supply Chain Business Analyst, on a contract basis. Job ID: 82493 Work Location: Summit, NJ - 50% on site (flexible to come more than 50% if needed) Job Title: Supply Chain Business Analyst- SAP ERP Summary: The Cell Therapy External Manufacturing ERP Systems business analyst is part of the Cell Therapy Vector & External Manufacturing Operations (VEXMO) organization and will support the ERP business process for the external network. This

LIMS Master Data Specialist

Katalyst Healthcares and Lifesciences

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

Cell Therapy SAP Sourcing Migration Specialist

Sunrise Systems, Inc.

Massachusetts, USA

Contract

Job Title: Cell Therapy SAP Sourcing Migration Specialist Job ID: 25-08158 Location: Devens, MA, 01434 Duration: 12 Month's Contract on W2 Onsite role Site Location: Work Schedule: Mon - Fri, Flexibility with work hour's key as this role does support both east and west coast teams Purpose and Scope of the Position: Seeking a highly skilled and experienced contractor to support the Direct Materials Sourcing initiatives and the implementation of a new ERP system (SAP) at multiple CLIENT sites. Th

Test Fixture Engineer II

Boston Scientific Corporation

Irvine, California, USA

Full-time

Additional Location(s): N/A 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 - whatever your

CSV Engineer

Sanofi

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

LMDS Process Engineering Co-op

Johnson & Johnson

Remote or Horsham, Pennsylvania, USA

Full-time

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

B57 Environmental Monitoring Lead

Sanofi

Swiftwater, Pennsylvania, USA

Full-time

Job title: B57 Environmental Monitoring Lead Location: Switftwater, 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: FFIP at Swiftwater produces over 100M doses for >10 drug products annually. The operation is a

Director, Artificial Intelligence and Machine Learning (AI/ML) Quality Oversight

Gilead Sciences, Inc.

Remote or Santa Monica, California, USA

Full-time

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great l

Process Engineer - Lilly Medicine Foundry

Eli Lilly and Company

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

Reliability Engineer (Onsite - Columbia, MO)

Solventum

Columbia, Missouri, USA

Full-time

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: continues to apply to any personal information you submit, and the 3M-branded positions lis