- Company Name
- EPM Scientific
- Job Title
- Qualification Execution Engineer
- Job Description
-
Job Title: Qualification Execution Engineer
Role Summary: Execute qualification activities (IQ, OQ, PQ, SAT) for critical manufacturing systems and controlled environments in a GMP‑compliant pharmaceutical setting, ensuring all systems meet regulatory and quality standards.
Expectations: Short‑term engagement (Jan – Apr 2026), full onsite presence, strong technical problem‑solving, collaborative approach with cross‑functional teams, and adherence to GMP and company quality policies.
Key Responsibilities:
- Lead execution of SAT, IQ, OQ, and PQ for equipment and facilities (filter‑dryers, vessel skids, pumps, cold/freezer rooms, unidirectional flow hoods, purified water and nitrogen systems, cleanroom classification).
- Prepare qualification plans, coordinate materials, teams, and timelines.
- Collect and review FAT, SAT, supplier documentation, and prepare reports.
- Identify, troubleshoot, and resolve technical issues during qualification.
- Capture and analyze test results, document non‑conformances, and trigger corrective actions.
- Provide technical support to the qualification team and collaborate with Production, Maintenance, QC, QA, and Engineering groups.
Required Skills:
- Knowledge of GMP and pharmaceutical qualification processes.
- Proficiency in IQ, OQ, PQ, SAT execution and documentation.
- Strong analytical and troubleshooting abilities.
- Effective communication and teamwork across cross‑functional departments.
- Detail‑oriented with strong organizational skills.
Required Education & Certifications:
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Relevant qualification certifications (e.g., QA/QAQC, GMP, or equivalent) preferred.