Validation Engineer Drug Manufacturing

Over deze vacature

Are you ready to make a real impact on product quality and patient safety? In this role, you’ll collaborate with a fellow Validation Engineer to bring our department’s filter validation processes to the next level. Together, you’ll ensure compliance with Annex 1 by validating all existing sterile filtration steps—critical for maintaining the highest standards in our operations.

What You’ll Be Doing

Your work will combine strategic planning with hands-on execution across multiple manufacturing sites. You will:

• Shape the Project: Develop a detailed validation roadmap for our IPT in partnership with the Sub System Owner for Sterile Filtration.
• Turn Plans into Action: Translate theory into practical steps and lead execution alongside your colleague and manufacturing teams.
• Validate with Precision: Perform both paper-based assessments and physical studies in our production areas and process development lab.
• Ensure Compliance: Document everything according to GMP and escalate risks promptly to keep the project on track.
• Solve Challenges: Collaborate with stakeholders to resolve technical, planning, and compliance issues.
• Drive Innovation: Identify opportunities to optimize processes—both technically and organizationally.

Your Impact

You’ll work within IPT Antigen, covering four manufacturing buildings and supporting sterile filtration for antigens, media, and buffers. This is a role where your expertise directly contributes to product integrity and patient safety.

Work Environment

Most of your work will be on-site, ensuring close collaboration with teams and access to our labs. After onboarding, remote work for 1–2 days per week can be arranged.

Wat we van jou verwachten

Educational Background: Engineering or scientific degree, preferably at BSc level or higher.

• Experience:BSc with 2+ years in Biopharma and GMP environments, or
• MSc with minimal experience may also be considered.

Skill Mix: Comfortable combining project management and technical writing with hands-on work in operations or the lab. Expect roughly 60–80% project coordination and documentation, and up to 30% practical execution.

Project Management: Prior experience is a strong plus.

Collaboration: Ability to communicate effectively across all levels—department MT, technical specialists, and operators.

Technical Expertise: Experience in sterilization validation, especially sterile filtration validation, is highly desirable.

Languages: Professional proficiency in Dutch and English is required.

Wat kun je van ons verwachten

TMC is een internationaal technisch consultancy bedrijf dat expertise levert aan onze klanten om ze te ondersteunen in het behalen van hun technische uitdagingen. Om dit te bereiken, werkt TMC als een expertise centrum voor zijn klanten om ze te helpen competitief te blijven in de veranderende Hightech- en materialensector. 

Bij TMC geloven we dat mensen de drijvende kracht zijn achter technische innovaties. Daarom creëren wij een omgeving waar technisch talent zich het beste kan ontwikkelen. Wij bieden jou een uitdagende en stimulerende omgeving waar jij de richting van je eigen carrière kan bepalen. 

Als een werkondernemer ben je onderdeel van de TMC familie. Naast onze uitstekende technische expertise is ook gezelligheid en betrokkenheid een belangrijk onderdeel van onze cultuur. 

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