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Senior Process Engineer (CDMO / Rotterdam)

Date Posted: May 24, 2024

Job Description

We are currently seeking a highly skilled Senior Process Engineer to join our team for a Contract Development and Manufacturing Organization (CDMO) project based in Rotterdam. The ideal candidate will have extensive experience in process engineering within the pharmaceutical or biotechnology industry and will be responsible for designing, optimizing, and maintaining manufacturing processes to ensure efficiency, quality, and regulatory compliance.

Key Responsibilities

  • Design, develop, and implement process engineering solutions to optimize pharmaceutical manufacturing processes and ensure regulatory compliance.
  • Lead process development and scale-up activities from laboratory to production scale, ensuring robust and reproducible manufacturing processes.
  • Collaborate with cross-functional teams to define process requirements and integrate new process solutions into existing manufacturing infrastructure.
  • Conduct process simulations, modeling, and analysis to identify opportunities for process improvements and efficiency gains.
  • Develop and implement process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Provide technical support and troubleshooting expertise for manufacturing processes, including diagnosing and resolving complex issues in a timely manner.
  • Develop and maintain comprehensive process documentation, including design documents, process flow diagrams, and standard operating procedures (SOPs).
  • Stay informed about industry trends, regulatory changes, and best practices in process engineering, and propose innovative solutions to enhance operational efficiency and compliance.
  • Mentor and guide junior engineers, providing technical expertise and fostering a collaborative work environment.

Required Qualifications and Skills

  • Bachelor’s degree in Chemical Engineering, Process Engineering, or a related field. Advanced degree preferred.
  • Minimum of 7 years of experience in process engineering within the pharmaceutical or biotechnology industry.
  • Strong understanding of pharmaceutical manufacturing processes and regulatory requirements (e.g., GMP, FDA).
  • Proven experience in process development, scale-up, and validation.
  • Excellent problem-solving skills and the ability to work effectively in a fast-paced, team-oriented environment.
  • Strong communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization.
  • Proficiency in process simulation and modeling software.
  • Proven track record of successful project delivery and adherence to project timelines and budgets.

If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.

Reference no.: 122-4948-2918-NW

Registration no.: 968446516E

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