Process Development Engineer

Location: Oss, Noord-Brabant  |  Sector: Pharmaceuticals  |  Start Date: 5/27/2024  |  Job ref: 52770

The Company
Our client is a top company that makes vaccines and medicines for animals. They’ve been researching and developing these products for 75 years, focusing on preventing infections in pets and farm animals. They also run the Dutch sales office and are committed to improving animal health worldwide.
Role description
We are looking for a motivated individual to join our External Manufacturing (ExM) Technical Operation organization in a Process Development Engineer. As part of our team, you will play a vital role in ensuring the smooth transfer of technology and the commercial production of Biological Drug substances at our External Partners (EPs). Your responsibilities will include supporting technology transfers, troubleshooting production issues, and optimizing processes and capacity. This position offers a wide range of opportunities across various areas such as Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
Responsibilities

  • Collaborate with External Partners to align with business objectives and foster a shared culture benefiting all stakeholders.
  • Manage technical aspects of commercial manufacturing processes at External Partners, including change control, process improvements, performance analysis, and event investigations.
  • Oversee technical transfer activities, ensuring compliance with GMP standards and regulatory requirements through documentation and filings.
  • Provide on-site support at External Partner facilities for Commercial and Technology Transfer activities.
  • Develop standardized procedures in line with GMP requirements and regulations, working closely with Operations, Quality, and External Partners.

Requirements

  • Bachelor’s degree in chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or related field.
  • Minimum 3 years of experience in GMP roles like Operations, Technical Operations, Technology, Engineering, or Maintenance.
  • Willingness to travel around 25% of the time.
  • Expertise in biologics drug substance operations, including upstream and downstream processes, analytical testing, process development, and tech transfer.
  • Proficiency in statistics, including Proactive Process Analysis and Continuous Process Verification.
  • Experience in deviation management, change control, equipment support, and project management.

Other Information
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About us

Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.