Periode: Project with possible permanent extension
Our client is a leading Project Management and Engineering Company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide Full Service Engineering for their clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors.
We are looking for someone who likes challenges, is collaborative and is keen on working within local as well as global project teams. We look for a candidate with strong knowledge and experience in bioprocessing and compliance. A self-starter, who would like to take initiative and can define new strategies for implementation of new equipment and products. In addition, a person, who demonstrated to lead projects and likes to coach and train team members.
- Primary responsible that validation studies are executed conform site standards and client's guidelines.
- This function encompasses cleaning, mixing and sterilization validation of production equipment.
- You are responsible to maintain and continue to improve the validation process.
- Defining and developing new validation strategies for the implementation of new equipment.
- Train and coach engineers in GMP compliance and perform the internal review of protocols and reports.
- You are responsible for preparation of protocols and execution of studies.
- Lead and support the coordination of studies.
- Participate in multidisciplinary projects as independent core team member.
- Assessment of change controls and preparing of validation assessments.
- Lead and Support in deviation investigations.
- Establish and maintain contact with colleagues of other (large molecule) sites.
- Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering).
- Must have 3+ year relevant experience in the (bio-) pharmaceutical industry.
- Precise, accurate, structured, flexible and customer focused.
- Proven experience with GMP and compliance.
- Expertise in process excellence and/or project management is a plus.
- Good communicative skills in English language (writing and verbal), Dutch is a plus.