MSAT Process Engineer

Vor 4 Tagen

Visp, Schweiz Capgemini Engineering Vollzeit

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Talent Acquisition Professional at Capgemini Engineering

We are seeking a highly skilled and experienced MSAT (Manufacturing Science and Technology) Process Engineer with a strong focus on process validation in the biopharmaceutical industry. The successful candidate will play a crucial role in ensuring the robustness and compliance of the biopharmaceutical manufacturing processes. As an integral part of our dynamic team, you will contribute to the optimization of manufacturing processes, technology transfer, and the validation of critical processes.

Responsibilities:

  • Process Validation Leadership: Lead and execute process validation activities for both upstream (e.g., cell culture, fermentation) and downstream (e.g., purification, filtration) biopharmaceutical manufacturing processes.
  • Development and Implementation: Design and implement robust validation strategies, author detailed protocols, and prepare comprehensive validation reports for new and existing processes.
  • Technology Transfer: Collaborate with cross-functional teams to ensure successful and seamless transfer of processes from development to manufacturing while maintaining consistency and quality.
  • Technical Expertise: Provide technical guidance during technology transfer activities, troubleshooting, and scaling up of processes to meet manufacturing requirements.
  • Continuous Improvement: Identify opportunities for process improvement and optimization, enhancing efficiency, product quality, and regulatory compliance.
  • Risk Assessment: Conduct thorough risk assessments for manufacturing processes and develop mitigation strategies to address identified risks.
  • Regulatory Compliance: Ensure all process validation activities adhere to current Good Manufacturing Practices (cGMP), regulatory requirements, and company standards.
  • Collaboration and Documentation: Work closely with internal and external stakeholders to align on project timelines, and maintain accurate documentation to support regulatory submissions and audits.

Requirements:

  • Bachelor's or Master's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field.
  • 5+ years of experience in process validation within the biopharmaceutical or pharmaceutical industry.
  • Strong knowledge of upstream and downstream biopharmaceutical processes.
  • Expertise in cGMP requirements, validation principles, and regulatory guidelines (e.g., FDA, EMA, ICH).
  • Proven experience in technology transfer, risk assessment, and process troubleshooting.
  • Excellent problem-solving and analytical skills.
  • Strong communication and teamwork abilities, with experience working in cross-functional teams.
  • Proficiency in technical writing for validation documentation and regulatory submissions.
  • Excellent oral and written language skills in English.

If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.

Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.

Capgemini Engineering is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.

Our offer

  • A permanent contract with the leader in innovation and high-tech engineering consulting.
  • A multi-stage model with career opportunities through specialization prospects with over 250,000 consultants around the world and a Group revenue of EUR 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
  • In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
  • Capgemini Engineering will be on the forefront in creating an optimal work-life balance, more autonomy in where and how our people work and to embrace the learnings we have experienced from wider-scale remote working. For you, this may mean less time in the office than usual with some time working from home, whereas other roles and engagements will continue to be more location-dependent or office-based. Together with your manager, you will agree an approach which works for you, your team and our business.
  • In order to deploy this novel way of working, we have introduced our New Normal policy which includes: 30% to 70% remote work in agreement with your line manager and client needs; Trust-based managerial culture; Team rituals and get together; Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.
Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Engineering, Consulting, and Manufacturing
  • Industries: Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research
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