Process System Engineer

工作内容

As the Process System Engineer for the Manufacturing Excellence CAR-T EMEA organization, you will be located in Ghent Belgium.

The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.

The team will drive process optimizations to enable seamless transition from clinical to commercial operations.

Key responsibilities:

• Will deploy the competence center for manufacturing equipment on cell therapy processes.
• Provides guidance and execution on aspects of design of experiments for manufacturing equipment
• Assure requalification of manufacturing equipment in case of improvements of post-investigation activities.
• Write, review and approval of equipment related characterization plans, protocols and reports upfront of equipment qualification.
• Will take the lead in introducing new technologies for specific type of equipment, sharing global platform competences and/or introducing best practices from other manufacturing facilities.
• Perform upgrades to and support the implementation of new process equipment, instruments and systems
• Implement or propose alterations, modifications, or replacement of existing equipment and systems to improve process reliability and reduce overall equipment lifecycle costs and process downtime
• Identify and provide support for the implementation of new and innovative cost & quality improvement initiatives for the successful development of business opportunities as required
• Support the creation of new practices, policies and procedures (e.g., SOPs, Work Instructions, etc.) pertaining to Operations, Engineering and Maintenance to enhance the performance of the business
• Support process driven quality events including (but not limited to): Deviations/Investigations, Out of Tolerances (OOTs), Change Controls, CAPAs, Root Cause Analysis and FMEA
• Participate in system and process improvement / optimization projects
• Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology
• Support process investigations with accurate knowlegde and competences.

Qualifications:

• Masters degree in Engineering (Mechanical/ Electrical, Bio), or equal in Biomedical Sciences or Pharmacy is required
• A minimum of five (5) years of experience in process engineering or operations within an industrial manufacturing or regulated environment is preferred.
• Experience in a controlled pharmaceutical cleanroom environment under aseptic conditions is preferred.

Experience and Skills:

• A good understanding of technical installations, process equipment, facilities and computerized systems within an industrial manufacturing or regulated environment.
• Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.
• Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
• Strong analytical, problem solving and critical thinking skills
• Ability to identify/remediate gaps in processes, equipment, facilities and business systems and to troubleshoot problems for highly technical equipment.
• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Experienced in working with validated and qualified process equipment and systems, and associated documentation.
• Project Management - provide timely and accurate reporting on project activities to peers and leadership
• Fluent in written and spoken Dutch and English

Key benefits:

As an answer to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting extras like:

• Meal vouchers of €7
• Net representation cost of €80
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings

We offer permanent, project and freelance contracts. And on top of this you’ll improve your skills and become an even bigger expert!

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion have been part of the cultural fabric and woven into how they do business every day. Their commitment to respect the dignity and diversity of all is embedded in their Credo.

They know that the success of their business depends on having the best talent in a workforce that reflects the diverse markets they serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion means “You Belong”.