Process Validation Scientist for Biologics DP

Vor 4 Tagen

Schaffhausen, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription

For our client, an international pharma company in Schaffhausen, we are looking for a Process Validation Scientist/Engineer for Biologics DP

The candidate should have expertise in ICH quality guidelines and late-stage biologic DP manufacturing. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable.

General Information:

  • Start date: ASAP / to be discussed
  • Duration: 1 year contract
  • Extension: possible, to be discussed
  • Workplace: Schaffhausen
  • Workload: 100%
  • Home office: possible in a hybrid model
  • Travel: Domestic ~25% of time based on role and specific business goals

Tasks & 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.
  • Influences others to accept new ideas, approaches or concepts or gains alignment on divergent issues.

Must Haves:
  • 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.
Marta Tomczyk

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