good manufacturing practice Jobs

81 - 100 of 967 Jobs

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,

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

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

Novo Nordisk IncCompany Name - Novo Nordisk Inc

•

Bloomington, Indiana, USA

Full-time

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.

Technical Product EngineerJob Title - Technical Product Engineer

Merck KgaACompany Name - Merck KgaA

•

Madison, Wisconsin, USA

Full-time

Work Location: Madison, Wisconsin Shift: No Department: LS-PS-JI Operations A Recruiter: Anthony Johnson This information is for internals only. Please do not share outside of the organization. Your Role: Mirus Bio has an immediate opening for a Technical Product Engineer that will use their expertise and technical background to boost the connectivity between our Quality, Operations, Product Management, and Commercial Teams. This role will serve as the technical Subject Matter Expert (SME) fo

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

IT infrastructure CSV ConsultantJob Title - IT infrastructure CSV Consultant

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting

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

Process Analytical Technology Strategy Leader Lilly Medicine FoundryJob Title - Process Analytical Technology Strategy Leader Lilly Medicine Foundry

Eli Lilly and CompanyCompany Name - 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

Validation EngineerJob Title - Validation Engineer

Salas O'Brien Engineers IncorporatedCompany Name - Salas O'Brien Engineers Incorporated

•

Houston, Texas, USA

Full-time

At Salas O'Brien we tell our clients that we're engineered for impact. This passion for making a difference applies just as much to our team as it does to our projects. That's why we're committed to living our values every day: inspiring, achieving, and connecting as shared owners of our success with a focus on a sustainable future. Building for the long-term means that all of our team members can expect to work on amazing projects with a people-first approach to problem solving. It also means

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

Quality Lab Associate II, 2nd ShiftJob Title - Quality Lab Associate II, 2nd Shift

BAXTERCompany Name - BAXTER

•

Lincolnshire, Illinois, USA

Full-time

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform h

Quality Lab Associate II, 2nd ShiftJob Title - Quality Lab Associate II, 2nd Shift

BAXTERCompany Name - BAXTER

•

Lake Geneva, Wisconsin, USA

Full-time

Senior Engineer - Engineering Technical AuthorityJob Title - Senior Engineer - Engineering Technical Authority

Amgen IncCompany Name - Amgen Inc

•

Remote or 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