Equipment Qualification Engineer
Job Overview
We are seeking a detail-oriented and proactive Equipment Qualification Engineer with 3 to 5 years of experience to join our site. This role focuses on managing the qualification lifecycle of GMP production and manufacturing equipment in a small molecule API production facility. The ideal candidate will spearhead new production equipment IQ/OQ executions, lead periodic requalification assessments, and execute mappings for environmentally controlled areas. You will work cross-functionally with Maintenance, Quality Assurance, Engineering, and Production to maintain our facility in a continuous state of compliance.
Key Responsibilities
New Production Equipment IQ/OQ
- Protocol Development & Execution: Draft, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for small molecule processing equipment.
- System Field Verification: Physically verify manufacturing equipment installations against P&IDs, vendor manuals, and site engineering specifications.
- Operational Testing: Evaluate and test production equipment functionality to assure adherence to functional requirements.
Requalification Activities
- Periodic Review Cycles: Perform periodic requalification evaluations of existing production systems to ensure they remain in a validated state.
- Deviation Resolution: Identify, investigate, and document technical deviations or out-of-specification results during qualification executions on the shop floor, authoring robust CAPAs to prevent recurrence.
Environmental Controlled Area Mapping
- Execution & Analysis: Execute mapping studies for controlled environmental areas, including raw material/finished goods storage areas while also providing support for stability and analytical chambers.
Required Skills & Qualifications
- Education: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related Life Sciences discipline.
- Experience: 3–5 years of validation or equipment qualification experience. Preferably in a cGMP-regulated pharmaceutical manufacturing environment, with a focus on manufacturing floor equipment.
- Collaborative Nature: Strong project management mindset coupled with the communication skills required to manage cross-functional initiatives across Facilities, Quality, and Operations teams.
