QA CQV - Mechanical QA Validation Engineer
Antwerp
Life Sciences - QA
Reference number: 91871
Join a dynamic project team dedicated to upholding the highest standards of quality and compliance within the pharmaceutical industry. We seek a motivated professional eager to contribute to our mission of ensuring rigorous quality in every aspect of the commissioning, qualification, and validation processes.
As the ideal candidate, you are a skilled QA Engineer with significant experience in mechanical quality assurance and validation, passionate about ensuring compliance with stringent industry standards. If you are detail-oriented and dedicated to quality, this role is perfect for you.
- You participate in validation risk assessments and provide quality input throughout project phases (Design, Commissioning, IOQ, PQ).
- You review and approve commissioning and qualification protocols, test scripts, and reports for manufacturing equipment and computerized systems.
- You verify that qualification activities are performed according to established procedures and regulatory requirements.
- You provide quality oversight during the execution of qualification activities.
- You review and approve change controls and other quality documentation related to CQV activities.
- You work closely with various teams including Commissioning, Qualification/Validation, Engineering, Manufacturing, and Technical Services.
- You provide quality guidance to stakeholders on validation requirements.
What are we looking for?
- You hold at least a Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific/technical field.
- You have a minimum of 3 years of experience in the pharmaceutical/biotech industry, focusing on CQV activities.
- Additional qualifications in Quality Assurance or Validation are a plus.
- You have demonstrated knowledge of qualification and validation principles.
- You possess experience with GMP manufacturing environments.
- You have a thorough understanding of EU GMP, FDA regulations, and ICH guidelines.
- You have excellent communication skills for effective collaboration with project teams.
- You are detail-oriented with a focus on assuring high-quality projects.
- You exhibit strong problem-solving abilities and the capacity to make decisions in dynamic project environments.
- You have multilingual proficiency for effective communication in diverse engineering contexts (English and Dutch).
- You have strong interpersonal skills and the ability to work in cross-functional teams.
- You are capable of managing multiple priorities and meeting deadlines.
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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