Process Validation Engineer for Biologics Development

vor 3 Wochen

Schaffhausen, Schaffhausen, Schweiz Randstad Vollzeit
Job Description

We are seeking a skilled Process Validation Engineer for Biologics DP to join our team at an international pharma company in Schaffhausen. This role will provide technical insight and support to DP leads in delivering qualification of equipment, aseptic process simulation, processing/hold times, and manufacturing processes in line with the supply chain network strategy and regulatory framework.



Key Responsibilities:
  • Support complex technology transfers with a focus on right-first-time execution and risk management.
  • Author, review, and approval of technical and regulatory documents (e.g., SOPs, work instructions, 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.


Requirements:
  • Engineer or 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 with 8+ years of experience.
  • Fluent in written and spoken English.
  • Proven track record in in at least three of these areas: DP comparability, Equipment qualification, Pharmaceutical process development, Technology transfer, Process validation.
  • Demonstrated technical competency and experience with biologic DPs.
  • Demonstrated experience in technology transfers 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 the 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 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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