The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

CQV Lead for Aseptic Fill/Finish Lines

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CQV Lead for Aseptic Fill/Finish Lines for a 12-month contract (extension planned) based in canton Aargau, Switzerland.

Main Responsibilities:

  • Interaction with Site Operation / Site QA / SGIE-Quality
  • Leading the assigned Team of Drug Product Ancillary Equipment and Lab Equipment
  • Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies
  • Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
  • Support / participate in validation activities during facility startup 
  • Provide leadership of CQV activities in assigned Project(s) in Switzerland (together with Site Operation, Site QA, SGIE-Quality):
  • Responsible for ensuring that CAPEX projects are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with the company’s continuous improvement vision.
  • Acting as subject matter expert on CQV standards
  • Keeping oversight on CQV -standards, -timelines (etc.)
  • Address immediate time/quality constraints and act adequately
  • Force RFT thinking and approach
  • Considering EHS Requirements
  • Involved and support PM and Process Engineers in CQV-Planning:
  • Development and delivery of CQV Documents
  • Commissioning Documents (Suppliers / Process Engineers/EMR)
  • QV-Documents (Suppliers / QV-Team /QA)

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Technical degree (Bachelor’s or Master’s) in engineering or applied science, post graduate qualification preferred.
  • Minimum of 12 years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics as well as chemical manufacturing technologies desirable.
  • Significant experience in qualification of aseptic filling lines and associated equipment such as vial washers, depyrogenation tunnels, filling machines, lyophilizers, cappers and isolators
  • Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.
  • Fluent English is a must, Fluent in German strongly beneficial

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.