Good manufacturing practice Jobs

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Validation Engineer

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

Validation Engineer

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

Validation Engineer

Katalyst Healthcares and Lifesciences

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

Validation Engineer III

Katalyst Healthcares and Lifesciences

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

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

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

Parenteral Commercialization Technology Transfer Lead

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 Engineer

Katalyst Healthcares and Lifesciences

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

CSV Engineer

Katalyst Healthcares and Lifesciences

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

Site Automation Project Engineer

Apex Systems

Philadelphia, Pennsylvania, USA

Full-time

Job#: 2074785 Job Description: Position Title: Site Engineering Automation Project Engineer Department: Site Engineering Job Location: Philadelphia, PA Contract & Onsite role Position Summary: The Site Engineering Automation Project Engineer will provide automation engineering design and project management support for a facility project located in Philadelphia, PA. This role will primarily be responsible for the Building Automation System (BAS), Environmental Monitoring System (EMS), and as

Global MES System Engineer - API New Facilities

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

Automation Engineer - 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

Senior Director, Global Process Automation and Controls, Engineering Technology Center

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

Engineer - Engineering Tech Center - Parenteral Network

Eli Lilly and Company

Durham, North Carolina, 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/Principal Engineer Visual Inspection - Parenteral

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

Senior Director, Parenteral Process Engineering, Engineering Technology Center

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

Associate Director - Digital Engineering Solutions

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

Manufacturing Engineer III (Andover, MA)

Sloan Valve Company

Andover, Massachusetts, USA

Full-time

JOIN AN INDUSTRY LEADER! Quality First & Green Always. Sloan is the world's leading manufacturer of commercial plumbing systems and has been in operation since 1906. We are at the forefront of the green building movement and provide sustainable restroom solutions. We manufacture water- efficient products including flush valves, electronic faucets, soap dispensing and sink systems along with vitreous china fixtures for commercial, industrial and institutional markets worldwide. About The Role:

IT Manager (Manufacturing)

PROLIM Global Corporation

Farmington Hills, Michigan, USA

Third Party, Contract

PROLIM Global Corporation ( is currently seeking IT Manager (Manufacturing) for location Farmington Hills, Michigan, United States for one of our Top clients. IT Manager (Manufacturing) Farmington Hills, Michigan, United States Job Description We are seeking an experienced and proactive IT Manager to lead our IT team at manufacturing facilities. This role is responsible for ensuring smooth IT operations, coordinating project activities, addressing technical issues, and maintaining strong communi

Manufacturing Engineer

Oxford Global Resources

Pearisburg, Virginia, USA

Full-time

Summary: Responsible for the design of tooling and equipment and in planning the manufacturing process for parts and assemblies for a designated manufacturing area. Work is of the technical nature where independent judgment is used and decisions are made within the limits of general practice policies. Works with minimal supervision. Project Details: Analyze assembly equipment for the best method of manufacture Specify tools, equipment and processes to produce a part or assembly, or evaluate pr