Qualification and Validation Engineer
Antwerp
Life Sciences - Validation and Qualification
Bachelor, Master
Work experience: 3-5
Reference number: 93065

Join a dynamic team where your skills will contribute to critical projects in the healthcare manufacturing sector. This role offers the opportunity to work in a challenging environment that prioritizes compliance and quality, making a significant impact on operations.

As an ideal candidate, you are a knowledgeable Validation Specialist eager to apply your expertise in ensuring regulatory compliance and quality assurance. If you possess a keen attention to detail and a strong commitment to excellence, this is a fantastic opportunity for you.

  • You develop, implement, and execute URS, CAT, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for small scale equipment in QC and Manufacturing.
  • You perform qualification of systems following industry standards, ensuring adherence to cGMP, cGLP, and internal procedures.
  • You maintain compliance of qualified systems with cGMP at all times.
  • You support projects in alignment with Sanofi and relevant regulatory standards.
  • You stay updated on emerging validation regulations and provide technical assistance on US FDA and EU requirements.
  • You take responsibility for validation documentation from approval through implementation.
  • You assess changes to determine their impact on qualified status and validation documentation.

What are we looking for?

  • You have between 2-4 years of experience in a healthcare manufacturing environment.
  • You possess knowledge of cGMP requirements in a regulated environment.
  • You are familiar with relevant quality and compliance regulations.
  • You have the ability to troubleshoot validation issues effectively.
  • You demonstrate good knowledge of quality management systems.
  • You are detail-oriented and capable of managing validation documentation.
  • You are proficient in English.

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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