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IQ/OQ/PQ Validation Engineer with Medical (W2)

Sovereign Technologies

•

Irvine, California, USA

Full-time

Title: Sr. Validation engineer with Medical Device Candidates Location: Onsite in Irvine, CA Duration: 2+ years 1) Word copy of resume 2) 2-3 professional references THIS IS NOT A SOFTWARE POSITION Looking for hands on IQ/OQ/PQ Validation in Medical Device Candidates MUST HAVE Bachelor of Science in Engineering or a related subject with 4+ years of experience in validation GMPs.Good understanding of engineering and machine tool fundamentals.Written and owned the validation processSME on IQ/OQ/PQ
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Posted 8 days ago | Updated 2 days ago

Component Engineer - Validation (IQ/OQ/PQ)

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.
Posted 4 days ago | Updated moments ago

Supplier Project Engineer

Gardner Resources Consulting, LLC

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Remote

Contract

Education and Experience: 3 years of relevant experienceBS Engineering Degree (Plastics, Mechanical, Manufacturing/Industrial) or related fieldPreferred Skills and Competencies: Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for component manufacturing processes and secondary Job Description Summary operations: Strong written and verbal communication skills Possess strong analytical and problem-solving skills Familiari
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Posted 28 days ago

Sr. CSV Engineer

New York Technology Partners

•

Muskegon, Michigan, USA

Contract, Third Party

Job Title: Sr. CSV Engineer Location: Muskegon, MI (Onsite- 5 days a week) Experience: 11+ years Must Have's: Validation of OT Systems such as DeltaV, manufacturing floor familiarity, life science background. JD from HM: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager.Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS an
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Posted 9 days ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Roles & Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems. They will review and approve risk assessment link to CSV of systems. Collaborate with the other departments, within their respective areas of responsibility for Change Managemen
Posted 5 days ago | Updated moments ago

Validations Engineer

Katalyst Healthcares and Lifesciences

•

Piscataway, New Jersey, USA

Full-time

Roles & Responsibilities: We're looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Experience with drafting and executing IQ/OQ/PQ. CAD proficiency to support the update of various P&IDs. Problem solving and troubleshooting skills to be able to identify and resolve issues through the validations. Good Communication and documentation Skills. Knowledge with USP water. Major job functions include generation of qualification / va
Posted 46 days ago | Updated moments ago

Process Engineer

Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Responsibilities: Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with pro
Posted 60+ days ago | Updated moments ago

CQV Validation Engineer

Katalyst Healthcares and Lifesciences

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Holly Springs, North Carolina, USA

Full-time

Job Description: We are seeking experienced CQV (Commissioning, Qualification, and Validation) Validation Engineers to join our team for immediate contract assignments. These roles are focused on the close-out phase of CQV activities for major capital projects within a fast-paced, regulated manufacturing environment. Responsibilities: Close Out CQV Protocols: Finalize and close out Commissioning, Qualification, and Validation protocols, including Installation Qualification (IQ), Operational Qua
Posted 21 days ago | Updated moments ago

Validations Engineer

Katalyst Healthcares and Lifesciences

•

Piscataway, New Jersey, USA

Full-time

Job Description: We're looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Roles & Responsibilities: Bachelor's degree. Experience with drafting and executing IQ/OQ/PQ. CAD proficiency to support the update of various P&IDs. Problem solving and troubleshooting skills to be able to identify and resolve issues through the validations. Good Communication and documentation Skills. Knowledge with USP water. Year of experience: 5&pl
Posted 48 days ago | Updated moments ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to
Posted 60+ days ago | Updated moments ago

Process Validation Engineer

Katalyst Healthcares and Lifesciences

•

Colorado Springs, Colorado, USA

Full-time

Responsibilities: Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio. Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requirement with R&D and design assurance against of part/product risk management file. Hands on driving and performing IQ, OQ, PQ and TMV at the suppliers. Strong Communicator to manage stakeholders and provide b
Posted 40 days ago | Updated moments ago

Sr Process Validation Engineer

Katalyst Healthcares and Lifesciences

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Franklin Lakes, New Jersey, USA

Full-time

Responsibilities: Author and execute Master Validation Plans (MVPs), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports in compliance with regulatory and internal standards. Lead validation activities for critical manufacturing processes including: Liquid phase mixing of formulation materials. Lyophilization (freeze-drying). Moulding and sizing of bioabsorbable components. Maintain and own Process FMEA (pFMEA) documentation and risk management files in
Posted 20 days ago | Updated moments ago

Process Validation Engineer

Katalyst Healthcares and Lifesciences

•

Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p
Posted 60+ days ago | Updated moments ago

Senior Supplier Quality Engineer

Jobot

•

Aurora, Colorado, USA

Full-time

Full-Time & Direct Hire Senior Supplier Quality Engineer needed for Global Health-Tech Leader! This Jobot Job is hosted by: James Thai Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $90,000 - $120,000 per year A bit about us: Based in Colorado Springs, CO, we are reimagining healthcare through breakthrough technologies and human-centered design. Our company is a global leader in health innovation, creating smart systems that improve lives
Posted 1 day ago | Updated 9 hours ago

Automation Engineer

Katalyst Healthcares and Lifesciences

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Keene, New Hampshire, USA

Full-time

Responsibilities: Support design reviews, debug, acceptance and validation activities for equipment being developed by external suppliers. Support decommissioning and recommissioning of equipment. Fundamental knowledge of statistical analysis - specifically GR&Rs & Process Capability. Experience with Allen-Bradley/Rockwell Automation programming, Studio5000, RSView ME/SE, Siemens S7 programming, Staubli/EPSON/ABB robot.Requirements: 4+ years' experience in a medical device manufacturing enviro
Posted 60+ days ago | Updated moments ago

Industrial Automation Engineer

Katalyst Healthcares and Lifesciences

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Keene, New Hampshire, USA

Full-time

Responsibilities: Support design reviews, debug, acceptance, and validation activities for equipment being developed by external suppliers. Support decommissioning and recommissioning of equipment. Fundamental knowledge of statistical analysis - specifically GR&Rs & Process Capability. Experience with Allen-Bradley/Rockwell Automation programming, Studio5000, RSView ME/SE, Siemens S7 programming, Staubli/EPSON/ABB robot. Requirements: 4+ years' experience in a Medical Device manufacturing e
Posted 60+ days ago | Updated moments ago

Controls/Automation Engineer

Katalyst Healthcares and Lifesciences

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New Jersey, USA

Full-time

Roles and Responsibilities: 4+ years' experience in a medical device manufacturing environment. Strong preference for assembly automation systems experience. Validation experience: IQ, OQ, PQ and TMVs utomation control systems background - PLCs, HMIs, Vision systems, Servos & Robots. Familiarity with standard MS Office tools. Good verbal and written communication skills. Support design reviews, debug, acceptance and validation activities for equipment being developed by external suppliers.
Posted 60+ days ago | Updated moments ago

Utilities Qualification(Validation) Engineer

Katalyst Healthcares and Lifesciences

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Salt Lake City, Utah, USA

Full-time

Job Description: A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer with 5+ years of experience in critical utilities validation and qualification. The candidate will support GMP manufacturing operations by qualifying and documenting systems like AHUs, purified water, compressed air, and legacy cleanroom systems. This is a fully onsite role and requires a self-driven individual with hands-on experience in IQ/OQ/PQ, EDMS tools (Glorya
Posted 60+ days ago | Updated moments ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 55 days ago | Updated moments ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Norwood, Massachusetts, USA

Full-time

Job Description: The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also
Posted 5 days ago | Updated moments ago