Process Validation Scientist – Aseptic Drug Products

Vor 7 Tagen

Zürich, Schweiz CTC Resourcing Solutions Vollzeit

Process Validation Scientist (Aseptic Drug Products) – 6284 URA

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Process Validation Scientist on a 12 months contract (yearly extendable) based in the Schaffhausen area in Switzerland.

This role provides regulatory expertise to support Drug Product leads in qualifying equipment, aseptic processes, and manufacturing timelines, ensuring alignment with supply chain strategies and compliance standards. Market Authorization experience is beneficial to securing this role, as this role lies in the Commercial supply chain organization.

Main Responsibilities:

  • Support complex technology transfers with a focus on right-first-time execution and risk management.
  • Translate late-stage regulatory DP manufacturing strategy into tech transfer plan.
  • Author, review, and approval of technical and regulatory documents (e.g., batch records, validation protocols, control strategy, and reports).
  • Support DP Process Performance Qualification and preparation of regulatory reports.
  • Support the internal and external teams in qualification of DP manufacturing equipment.
  • Perform as SME to identify technical areas for improvement and supply chain improvement.
  • As needed, provide SME input on change management, product impact assessment, and implementation of changes to the DP manufacturing processes.
  • Influence others to accept new ideas, approaches, or concepts or gain alignment on divergent issues.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals or bachelor’s degree + 8 years of experience.
  • Proven track record in at least three of these areas:
  • Drug Product comparability
  • Equipment qualification
  • Pharmaceutical process development
  • Experience in secondary Technology transfer
  • Process validation
  • Demonstrated technical competency and experience with biologic DPs.
  • Demonstrated experience in technology transfer projects.
  • Partnering with R&D and commercial supply to improve the fit for plant and commercialization of new products into the supply chain.
  • Personal and interpersonal skills / Leadership skills.
  • Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.
  • Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.
  • Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through various matrix teams.
  • Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks and goals and manage time accordingly.
  • Ability to manage complexity and change.
  • Motivated, self-starter able to work independently with demonstrated problem-solving skills.
  • Drives for innovation and change to ensure competitiveness.
  • Can-do mentality: takes initiative, creates a result-oriented working spirit in his/her team.
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