good manufacturing practice Jobs

101 - 120 of 1,070 Jobs

Principal EngineerJob Title - Principal Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Round Lake, Illinois, USA

Full-time

Job Description: Design, develop, integrate, test, evaluate or improve integrated systems or related processes, primarily with human factors, quality control, inventory control, and material flow, cost analysis, and production coordination. Must work with manufacturing personnel, quality, labs, supply chain, and site leadership to improve the quality and efficiency of processes, increase productivity and decrease costs. Responsibilities: Other duties may be assigned: -Take ownership of the ma

Technician III, Engineering - Process (Multiple Shifts)Job Title - Technician III, Engineering - Process (Multiple Shifts)

Novo Nordisk IncCompany Name - 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 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 fill/finish and packaging. T

Technician II, Engineering - Process (Multiple Shifts)Job Title - Technician II, Engineering - Process (Multiple Shifts)

Novo Nordisk IncCompany Name - Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

Validation EngineerJob Title - Validation Engineer

Merck KgaACompany Name - Merck KgaA

•

Miamisburg, Ohio, USA

Full-time

Work Location: Miamisburg, Ohio Shift: No Department: LS-SC-PEMM Engineering & Maintenance Recruiter: Renay Middleton Hiring Manager: John Shay This information is for internals only. Please do not share outside of the organization. Your Role: In this role you will develop and execute validation protocols to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role is crucial for maintaining the quality and integrity of manufacturing processes and produ

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Lexington, Massachusetts, USA

Full-time

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; Write and execute qualification protocols for new equipment and decommissioning protocols for old equipment. Execute approved protocols per company Good Documentation Practices (cG

Technician II, Engineering - Process (Weekend Nights)Job Title - Technician II, Engineering - Process (Weekend Nights)

Novo Nordisk IncCompany Name - Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

Technician II, Engineering - Process (Days)Job Title - Technician II, Engineering - Process (Days)

Novo Nordisk IncCompany Name - Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

CQV EngineerJob Title - CQV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Holly Springs, North Carolina, USA

Full-time

Responsibilities: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC). Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis. Supporting clients change management program - including authoring proposed changes, executing impact assessments/ regression analysis,

Senior Process Control Engineer - Berkeley, CAJob Title - Senior Process Control Engineer - Berkeley, CA

Bayer CorpCompany Name - Bayer Corp

•

Berkeley, California, USA

Full-time

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

Component Engineer - Validation (IQ/OQ/PQ)Job Title - Component Engineer - Validation (IQ/OQ/PQ)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Roles & Responsibilities: Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

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

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

Novo Nordisk IncCompany Name - Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

Sr. Engineer Drug Substance Facility ProjectsJob Title - Sr. Engineer Drug Substance Facility Projects

Amgen IncCompany Name - Amgen Inc

•

Holly Springs, North Carolina, 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 eac

Engineer III, AutomationJob Title - Engineer III, Automation

ICU Medical, Inc.Company Name - ICU Medical, Inc.

•

Southington, Connecticut, USA

Full-time

Job Description Position Summary The Engineer , Controls will provide technical leadership for the evaluation and implementation of automation and controls improvements to enhance the efficiency, quality, compliance, and safety of manufacturing operations. Evaluate existing process controls and suggest and evaluate controls improvements. Work closely with maintenance. Provide technical support to large projects, including automation design, implementation, and validation. Support manufacturing

Engineer, Engineering - Process (Days)Job Title - Engineer, Engineering - Process (Days)

Novo Nordisk IncCompany Name - Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

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

Startup EngineerJob Title - Startup Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Bachelor's degree in engineering, construction science, life sciences, chemical engineering, biochemical engineering, or related field. Minimum of five (5) years of pharma/biotech manufacturing experience in providing engineering, commissioning, or validation support. In depth understanding of application of cGMP principles, concepts, practices, and standards. Equipment, facilities, and utilities commissioning and/or qualification experience needed. Process safety manag

Validation Engineer with cGMPJob Title - Validation Engineer with cGMP

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

South Carolina, USA

Full-time

Job Description: This position is responsible for writing, implementing, analysing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. Will include developing and accessing following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validat

EngineerJob Title - Engineer

ACL DigitalCompany Name - ACL Digital

•

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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

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