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Manufacturing Systems Engineer - II (Associate)

Spectraforce Technologies
United States, Pennsylvania, West Point
Apr 10, 2026
Job Title: Manufacturing Systems Engineer - II (Associate) Location: West Point, PA 19486 Duration: 8 Months Summary: We are seeking a detail-oriented professional with experience in computer system validation and GMP-regulated environments to support periodic reviews of laboratory and manufacturing systems. This role involves cross-functional collaboration, technical documentation review, and on-site system inspections. Key Responsibilities: Collaborate with cross-functional teams across the West Point site to support system compliance activities. Perform periodic reviews of laboratory systems and manufacturing equipment. Manage periodic review schedules and generate detailed compliance reports. Review and verify system procedures, including backups and security protocols. Evaluate SDLC documentation to ensure alignment with internal and regulatory requirements. Assess system events, logs, and issues to ensure optimal performance and compliance. Review calibration and maintenance records for accuracy and completeness. Evaluate completed change control records for compliance. Analyze collected data and prepare comprehensive reports outlining findings and conclusions. Support implementation of computerized maintenance systems through data review and evaluation. Must-Have Skills: Knowledge of computer system validation (CSV) processes Understanding of Software Development Life Cycle (SDLC) Experience in GMP / regulated environments (cGxP) Strong technical writing and documentation skills Solid computer proficiency Ability to work independently Preferred Skills: Experience with Kneat (electronic validation system) Familiarity with lab systems and manufacturing equipment Leadership or facilitation experience Education & Experience: Bachelor's degree in Engineering or Science 2+ years of experience in the pharmaceutical or regulated industry Work Environment: Onsite role - West Point Requires walking through labs, inspecting systems and equipment Interaction with lab owners and stakeholders across departments