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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 49 days ago | Updated 4 hours 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 4 hours ago

Sr Process Validation Engineer

Katalyst Healthcares and Lifesciences

•

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 29 days ago | Updated 4 hours ago

CQV Engineers Needed - Spring House, PA_Onsite job

Stellent IT LLC

•

Spring House, Pennsylvania, USA

Contract, Third Party

Hiring for - TITLE - CQV Engineers - Spring House, PA_Onsite job They are going to need 25-30 CQV Engineers to assist on this project. Initial 6 12-month project. The areas of focus will be on Cell Therapy and Temperature mapping Need - LINEKDIN match with updated resume, no FAKE people Multiple CQV Engineers needed to support a project in Spring House, PA. The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and lab
Easy Apply
Posted 3 days ago | Updated 20 hours ago

Industrial Automation Engineer

CA-One Tech Cloud Inc.

•

Lithia Springs, Georgia, USA

Contract

Required Skills and Experience: Bachelor s degree in Electrical Engineering, Automation, Mechatronics, or related field.5+ years of experience in industrial automation and control systems.Strong hands-on experience with PLC programming (e.g., Siemens, Allen-Bradley, Schneider).Familiarity with SCADA systems, OPC UA/DA, MQTT, and industrial communication protocols.Experience with IIoT platforms and edge computing devicesDeep expertise with Ignition by Inductive AutomationExperience working in GMP
Easy Apply
Posted 2 days ago | Updated 2 days ago

Automation Engineer

Katalyst Healthcares and Lifesciences

•

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 4 hours ago

Industrial Automation Engineer

Katalyst Healthcares and Lifesciences

•

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 4 hours ago

Utilities Qualification(Validation) Engineer

Katalyst Healthcares and Lifesciences

•

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 4 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

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 60+ days ago | Updated 4 hours 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 14 days ago | Updated 4 hours ago

Principal 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 7 days ago | Updated 13 hours ago

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
Posted 60+ days ago | Updated 4 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 24 days ago | Updated 4 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 4 hours ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

•

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 60+ days ago | Updated 4 hours ago

Process Engineer II

Johnson & Johnson

•

Cornelia, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 15 hours ago | Updated 4 hours ago

Commissioning and Qualification Engineer

Katalyst Healthcares and Lifesciences

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Raleigh, North Carolina, USA

Full-time

Responsibilities: Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements. Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance. Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities. Perform process equipment qualification to meet GMP and production readiness standards. Develop and execute C&Q pro
Posted 60+ days ago | Updated 4 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

St. Louis, Missouri, USA

Full-time

Responsibilities: The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently. Support onsite and offsite activities, such as: FATs, SATs, IOQ
Posted 60+ days ago | Updated 4 hours ago

Manufacturing Engineer (Onsite - Columbia, MO)

Solventum

•

Columbia, Missouri, USA

Full-time

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: continues to apply to any personal information you submit, and the 3M-branded positions lis
Posted 14 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Nashville, Tennessee, USA

Full-time

Responsibilities: Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes: These confirm proper functionality and adherence to operational specifications. Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products. Conduct revalidation of equipment and processes when changes occur, such as: ssess risks related to equipment, processes, and production areas that could impact product qua
Posted 60+ days ago | Updated 4 hours ago