Jobid=4230a3cdab75 (0.1002)
Location: Haarlem
Duration: 12 Months (possible extension)
Full time
Are you an experienced Validation Engineer passionate about quality, compliance, and improving pharmaceutical manufacturing processes? We are looking for a driven professional to support and lead equipment qualifications and validation activities in a dynamic GMP environment.
What You Will Do
- Lead and execute IQ, OQ, and PQ qualification activities.
- Support validation and requalification efforts for steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, and airflow visualization/smoke studies.
- Document, track, and close deviations and change controls.
- Provide technical guidance to project teams and stakeholders on validation-related topics.
- Ensure alignment of validation activities with production schedules and project timelines.
- Perform risk assessments and impact analyses, proposing effective mitigation strategies.
- Draft, review, and evaluate validation data, reports, deviations, and periodic reviews in line with GMP/GDP standards.
- Act as a Subject Matter Expert (SME) during internal and external audits/inspections.
- Mentor and train junior validation team members.
What You Bring
- Bachelor's degree or higher in a relevant engineering or scientific field.
- 4-5 years of experience in validation or CQV within the pharmaceutical industry.
- Strong understanding of GMP, V-Model, and SDLC methodologies.
- Excellent analytical, problem-solving, and organizational skills.
- Team-oriented mindset with a proactive “can-do” attitude.
- Strong communication skills and the ability to work effectively with cross-functional teams.
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