PQ/GO LIVE Document Engineer MES
Antwerp
Life Sciences - Validation and Qualification
Bachelor, Master
Work experience: 3-5
Reference number: 89600
Join a pioneering team in the biopharmaceutical industry where your expertise will ensure the utmost quality of Manufacturing Execution Systems (MES) projects supporting cutting-edge CAR-T therapies. You will thrive in an innovative environment dedicated to transforming patient care and streamlining production processes.
As the ideal candidate, you are a detail-oriented PQ/GO Live Document Support Engineer MES with a passion for enhancing operational quality and facilitating seamless collaboration across diverse teams. If you have experience in documentation creation and compliance in the pharmaceutical sector, this position offers you the chance to make a meaningful impact.
- You create standard operating procedures (SOPs), user manuals, and work instructions related to MES.
- You develop validation documentation such as test plans (IQ/OQ/PQ), deviation reports, and change control documents.
- You execute and document MBR (Master Batch Record) verification and compliance documentation.
- You collaborate with technical teams to translate complex processes into clear documentation for users.
- You ensure all documentation complies with Good Manufacturing Practices and relevant guidelines.
- You develop training materials for end users and support MES implementation.
- You track changes to ensure documentation is up-to-date with new releases and regulations.
What are we looking for?
- You hold a Bachelor’s or Master’s degree in a technical field, such as Engineering or Computer Science.
- You have at least 2 years of cross-functional experience in the pharmaceutical industry.
- You possess strong knowledge and understanding of cGMP regulations.
- You have experience with Master Batch Records and/or quality assurance in production environments.
- You have experience with MES systems in production environments (strong advantage).
- You demonstrate strong analytical thinking and decision-making skills.
- You are an excellent communicator with a solution-oriented attitude.
- You have the ability to work independently and as part of a team.
- 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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Julie Bataille
Key Account Manager Life Sciences, Food and Biotech
0032496729973
