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Senior Validation Engineer - Freelance (m/f/x)

New
  • Location: Hesseneck
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted etwa 14 Stunden her

  • Sector: Pharmabranche
  • Contact: Eric Bolender
  • Contact Email: e.bolender@sciproglobal.de
  • Duration: 6 Monate +
  • Start Date: ab August 2023
  • Expiry Date: 04 June 2023
  • Job Ref: QF_2023_8_1683278748

Project Description:

  • Writing and reviewing cleaning verification, (re)validation and annual assessment protocols and reports, and ensuring these comply with our global cleaning policies, procedures and guidelines, and external regulatory requirements;
  • Planning and coordinating the execution of (annual) cleaning validation activities together with operations and scheduling;
  • Writing and maintaining Master Cleaning batch records;
  • Coordinate and author cleaning related events (deviations), including performing impact assessment, root cause analysis, and CAPA development/implementation;
  • Organizing, performing and reporting annual / baseline visual inspections of product contact equipment;
  • Providing technical and hands-on support towards Operations with regard to cleaning processes and cleaning validation activities;
  • Supporting cleaning development, e.g. soil characterization, and swab recovery testing;
  • Driving improvements in cleaning (validation) processes and leading efforts in completing the intended improvements;
  • Depending on department needs and your experience, the role may include the above responsibilities for sterilization (validation) for autoclave or hot air sterilizers

Requirements:

  • Knowledge of regulatory cleaning validation expectations, sterilization process (validation)
  • Proficient in cGMPs and EHS as it applies to the pharmaceutical industry

Details:

  • Capacity: fulltime (min. 0,8 FTE)
  • Timeline: 6 months +
  • Start: August 2023