- Company Name
- EP2C ENERGY
- Job Title
- Ingénieur Qualification / Validation
- Job Description
-
**Job Title**
Qualification & Validation Engineer
**Role Summary**
Lead the planning, execution and documentation of qualification and validation activities for sterilization equipment, biotechnological processes, quality control instruments and environmental controls within a GMP‑certified manufacturing site. Ensure compliance with international regulations (GMP, BPF, FDA, ICH Q9/Q10) and support regulatory inspections.
**Expectations**
- Develop and maintain the Validation Master Plan, IQ/OQ/PQ schedules and associated documentation.
- Execute validation protocols, analyze results, and prepare detailed reports for audits and regulatory submissions.
- Manage non‑conformances, change requests and CAPA activities related to validation scope.
- Provide training and technical support to operational teams on qualification best practices.
**Key Responsibilities**
- Define qualification and validation strategy across Biotech, QC, sterilization and environmental control domains.
- Draft, review and approve VMP, IQ/OQ/PQ plans and protocols.
- Conduct equipment qualification (autoclaves, bioreactors, chromatography skids, QC instruments such as HPLC, GC, ICP‑OES, spectrophotometers).
- Perform environmental qualification (EMPQ, disinfection studies, particulate & microbiological monitoring).
- Update and control certification documents in the electronic quality management system (eQMS).
- Investigate non‑conformities, initiate corrective actions, and monitor CAPA closure.
- Collaborate with Quality, Production, Metrology and Project teams to align validation activities.
- Prepare and defend validation dossiers during internal audits and regulatory inspections.
- Train and mentor operational staff on qualification and validation requirements.
**Required Skills**
- Minimum 4 years of hands‑on qualification/validation experience in pharmaceutical or biotechnological manufacturing.
- In‑depth knowledge of GMP/BPF, FDA, EMA, ICH Q9/Q10 regulatory frameworks.
- Technical proficiency in equipment qualification (autoclave PQ, bioreactors, chromatography skid, filtration units, QC analytical instruments).
- Ability to develop acceptance criteria, sampling protocols and performance monitoring strategies.
- Strong analytical, documentation and project‑management skills.
- Operational English proficiency for technical communication and documentation.
**Required Education & Certifications**
- Master’s degree (≈ Bac + 5) in Pharmacy, Biotechnology, Chemistry or Process Engineering.
- GMP/BPF qualification training; familiarity with FDA/EMA regulatory requirements is essential.
---