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Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 60+ days ago | Updated moments ago

Senior SAP PP/PM Functional Consultant (Manufacturing & Maintenance)

Value Global, LLC

•

Atlanta, Georgia, USA

Contract

Job Title: Senior SAP PP/PM Functional Consultant (Manufacturing & Maintenance) Location: Atlanta, GA Duration: 12+ Months contract with possible extension/conversion Job Overview: Seeking a highly experienced SAP PP/PM implementation specialist with deep domain expertise in pharmaceutical manufacturing and equipment maintenance. The consultant will lead comprehensive manufacturing implementations, bringing extensive knowledge of production planning, quality integration, and maintenance strategi
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Posted 2 hours ago

Senior Manufacturing Engineer

Olympus Corporation of the Americas

•

Brooklyn Park, Minnesota, USA

Full-time

Working Location: MINNESOTA, BROOKLYN PARK Workplace Flexibility: Onsite For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn mo
Posted 11 days ago | Updated moments ago

Validation Engineer

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
Posted 19 days ago | Updated moments ago

Manufacturing Engineering Technician

Gentex Corp.

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Manchester, New Hampshire, USA

Full-time

Job Type Full-time Description GENTEX AT A GLANCE: At Gentex Corporation, we've created an environment where great ideas and great people can thrive. Leveraging a history that spans over 130 years, Gentex is a global leader in personal protection and situational awareness solutions for defense forces, emergency responders, and industrial personnel operating in high performance environments. Join our multinational team of exceptional and dedicated employees around the world and work on challen
Posted 13 days ago | Updated 15 hours ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 60+ days ago | Updated moments ago

Validation Engineer NPI

Katalyst Healthcares and Lifesciences

•

Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical
Posted 60+ days ago | Updated moments ago

Process Engineer III

Novo Nordisk Inc

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Lebanon, New Hampshire, USA

Full-time

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, a
Posted 60+ days ago | Updated moments ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Durham, North Carolina, USA

Full-time

Job Description: Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This
Posted 17 days ago | Updated moments ago

Controls Engineer

Merck KgaA

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Jaffrey, New Hampshire, USA

Full-time

Work Location: Jaffrey, New Hampshire Shift: No Department: LS-SC-PEJBAH Jaffrey Controls Engineering Recruiter: Katherine Hall Hiring Manager: Lemuel Gomez This information is for internals only. Please do not share outside of the organization. Your Role: In this role you are primarily responsible for providing innovative automated solutions through collaboration with equipment suppliers and internal colleagues. In this role you will be handling multiple projects at the same time, be hands o
Posted 20 days ago | Updated moments ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

•

San Francisco, California, USA

Full-time

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 60+ days ago | Updated moments ago

Manufacturing Engineer

Pentair

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Backus, Minnesota, USA

Full-time

Job Description: At Pentair, you will work alongside passionate problem-solvers who are committed to the future of our planet. We put our purpose into practice, helping people sustainably move, improve, and enjoy water, life's most essential resource. From our residential and commercial water solutions to industrial water management and everything in between, our 9,750 global employees serve customers in more than 150 countries, working to help improve lives and the environment around the world
Posted 29 days ago | Updated 21 hours ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati
Posted 60+ days ago | Updated moments ago

Validation Engineer

Apex Systems

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Lebanon, Indiana, USA

Full-time

Job#: 2078205 Job Description: Role: Equipment Validation Engineer Location: Indianapolis, IN (On-Site) Type: Long Term Contract Apex Systems, a global leader in Technology Services, is searching for an Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details! Duties and Responsibilities: Supports the
Easy Apply
Posted 55 days ago | Updated moments ago

Process Engineer I - Downstream Process Support

Novo Nordisk Inc

•

Lebanon, New Hampshire, USA

Full-time

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What we offer you: Leading pay and annual performance bonus for all positions36 Paid days off including vacation, sick days & company holidaysHealth Insurance, Dental Insurance, Vision InsuranceGuarant
Posted 38 days ago | Updated moments ago

Automation Engineer

Owens Corning

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Fort Mill, South Carolina, USA

Full-time

BRIEF DESCRIPTION: Reporting to the TPM & Facilities Manager, the Manufactoring Engineer is responsible for developing, improving, and maintaining efficient manufacturing processes. This role involves working closely with the production team to ensure that products are manufactured to the highest standards of quality and efficiency. The Manufacturing Engineer will also implement new technologies and methodologies to enhance production capabilities. KEY DELIVERABLES: Analyze current manufacturin
Posted 14 days ago | Updated moments ago

Mechanical Design Engineer

Katalyst Healthcares and Lifesciences

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Sunnyvale, California, USA

Full-time

Job Description: Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and imp
Posted 5 days ago | Updated moments ago

Mid Tooling and Validation Engineer

Bytecubit Technologies

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Buffalo Grove, Illinois, USA

Contract

Job Title: Mid Tooling and Validation Engineer Location: Buffalo Grove, IL Duration: 3+ months Pay Rate: $40-55hr(Depending on experience) Job Description: Need to hire consultant for injection molding projects. This candidate will start on one project and move to another to help fill the gaps. May include some travel to support molding FOT/FAT activity. Must Have Skills/Experience: 3 years toolmaking 3 years tooling engineering Solidworks Nice to Have Skills/Experience: Mold Validation (IQ/OQ/P
Easy Apply
Posted 8 days ago

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

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Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee
Posted 60+ days ago | Updated moments ago

Validation Engineer 4

Katalyst Healthcares and Lifesciences

•

Littleton, Colorado, USA

Full-time

Job Description: We are seeking a detail-oriented and experienced LabVantage Business Analyst to support the implementation, optimization, and ongoing support of LabVantage LIMS (Laboratory Information Management System). The ideal candidate will work closely with business stakeholders, scientists, QA teams, and IT to gather requirements, analyze workflows, and ensure that LabVantage solutions align with organizational needs. Responsibilities: ct as the liaison between scientific/business teams
Posted 60+ days ago | Updated moments ago