We are looking for a Qualification engineer for a client in the pharmaceutical industry. As Qualification engineer you will be responsible to make sure analytical chemical lab equipment is and stays validated and qualified.
Job Description:
We are looking for an experienced technician or engineer with proven experience in validation and and (re-) qualification of analytical lab equipment (HPLC, GC, UV-VIS, TOC, FT-IR, etc). The position involves Project work and collaboration with QA (Change control, and CAPA's). You will play a crucial role in ensuring compliance with regulatory requirements and industry standards.
Responsibilities:
- Lead and actively participate in equipment qualification activities, encompassing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Execute validation protocols/plans for validations/qualifications of HPLC, GC-MS, UV-VIS, TOC and FT-IR.
- Provide technical expertise and guidance on validation-related issues in project teams.
- Collaborate with cross-functional teams to align validation activities with production schedules, project timelines, and quality expectations.
- Draft, review, and assess validation data, deviations, and change controls, ensuring compliance with regulatory requirements and internal quality standards.
- Uphold Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) during validation activities.
Profile:
- Bachelor's or higher degree in a relevant scientific or engineering discipline.
- A minimum of 3 years of experience in validation/CQV in the pharmaceutical industry.
- Knowledge of GMP.
- Hands on experience with HPLC/UVVIS/GCMS/FTIR.
- Strong analytical, problem-solving, organizational, and project management skills.
- Team player with attention to detail and a strong can-do mentality.
Benefits and practical information:
- Salary range: 3300-4500.
- Standard business hours: Full-time position
- Contract type: Temporary position, first contract through Oxford
- Region: Haarlem
Vacaturenummer: 24942
