Together with a leading CDMO, we are looking for a Commissioning, Qualification & Validation (CQV) Engineer to support validation activities for equipment and facilities in a GMP-regulated environment.
Key Responsibilities
- Coordinate the installation and validation of equipment and utilities.
- Draft, execute, and document IQ/OQ/PQ protocols in compliance with cGMP requirements.
- Prepare validation documentation, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and validation protocols.
- Execute IQ/OQ/PQ for equipment, systems, and utilities.
- Perform GAP analyses and risk assessments related to validation activities.
- Identify process efficiencies and integrate lessons learned into validation strategies.
- Stay up to date with industry regulatory changes and ensure compliance.
- Support Quality Systems activities such as Document Management, Change Control, Non-Conformities, and CAPAs.
- Write and revise SOPs and procedures related to engineering and validation activities.
- Assist in validation, requalification, and maintenance programs within the Engineering group.
Requirements
- Education: Bachelor’s degree in Science or a technical field.
- Experience: 5–10 years in the pharmaceutical industry with advanced experience in CQV.
- Technical Skills:
- Strong experience in validation lifecycle management.
- Excellent technical writing skills for protocols and reports.
- Knowledge of cGMP, risk assessments, and regulatory requirements.
- Soft Skills:
- Strong organizational and time management abilities.
- Excellent written and verbal communication skills.
- Ability to collaborate interdepartmentally.
Practical Information
- Contract: 8 months, with the possibility of extension.
- Location: Visp, Switzerland.
- Languages: English required, additional languages are a plus.
If you are interested in this opportunity, apply now by sending your application at f.karampina@panda-int.com.
Interviews and offer can be happening next week - so let's connect today!