We are seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485). Hands-on role focused on protocol execution, technical troubleshooting, and direct coordination with the client's team and equipment vendors.
Responsibilities:
• Develop, execute, and close IQ/OQ/PQ protocols and summary reports for manufacturing equipment and utilities.
• Troubleshoot equipment and execution issues, determine root cause, and drive resolution to closure.
• Work hand-in-hand with the client's engineering, quality, and manufacturing teams, and coordinate with equipment vendors/OEMs for technical support when required.
• Support the full Validation Life Cycle: planning, URS/FRS, risk assessment (FMEA), RTM, execution, deviations, and closure.
• Assess validation impact of equipment changes and support change control activities.
Requirements:
• Bachelor's Degree in Engineering. Required — no equivalent substitutions.
• Minimum of five (5) years of validation experience in medical device or pharmaceutical manufacturing.
• Hands-on equipment validation experience (IQ/OQ/PQ development and execution).
• Proven troubleshooting capability, including direct interaction with vendors/OEMs.
• Working knowledge of the Validation Life Cycle, cGMP, and FDA 21 CFR Part 820.
• Strong technical writing skills. Fully bilingual (English/Spanish).
• Availability to support production schedules, including off-shift coverage as required.
