Join a dynamic project team where your expertise as a
QA Construction Engineer
will significantly contribute to establishing a new production facility that prioritizes quality and compliance. This role offers you a chance to ensure that our facility meets all regulatory and GMP requirements through its entire lifecycle.
As our ideal candidate, you are a seasoned
QA Construction Engineer
who is detail-oriented and committed to maintaining high-quality standards in the pharmaceutical industry. If you are passionate about construction oversight and compliance, this position could be the perfect match for you.
Tasks
* You provide QA oversight during all phases of construction, including monitoring and pre-commissioning.
* You review and approve construction documentation, drawings, and specifications from a GMP perspective.
* You ensure construction activities comply with pharmaceutical industry standards and regulatory requirements.
* You provide quality input on facility, materials, and systems.
* You coordinate with architects, contractors, and engineering teams to ensure GMP compliance.
* You monitor construction milestones and quality checkpoints.
* You conduct facility inspections and document compliance with specifications.
* You prepare for and support facility licensing activities.
* You collaborate with cross-functional teams, including Engineering, Manufacturing, and Regulatory Affairs.
* You ensure proper documentation and traceability throughout the construction process.
What are we looking for?
* You hold at least a
Bachelor's degree
in Engineering, Pharmaceutical Sciences, Chemistry, or a related technical field.
* You have a minimum of
5 years of experience
in the pharmaceutical or biotech industry with a focus on facility construction or CQV.
* You bring experience with
GMP facility design
and construction projects.
* You possess strong knowledge of
EU GMP
, FDA regulations, and facility qualification requirements.
* You have an understanding of HVAC, utilities, and cleanroom design principles.
* You are proficient in communication and project coordination.
* You have the ability to read and interpret technical drawings and specifications.
* You demonstrate strong attention to detail and documentation skills.
* You are proficient in
English
and ideally also in
Dutch
.
* You can work effectively in construction environments and conduct site inspections.