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Job Details

Senior Validation Engineer

Company: Edelway Switzerland AG
Location: Zurich area
Reference: SJ-04
Closing Date: 17 Aug 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Edelway is a pan-European Pharma Consultancy. One of our best clients, a global, pharmaceutical company based in Zurich Area, Switzerland is currently looking for experienced Senior Validation Engineer.

Requirements:

Responsibilities:

The Senior Validation Engineer independently completes activities related to the items below:

  • Ensuring all aspects of Cleaning and Sterilization Validation adhere to global policies, procedures and guidelines and external regulatory requirements.
  • Generating and executing validation protocols to demonstrate compliance to a standard suitable for review by internal and external auditors.
  • Authoring, Review and/or Oversight of cleaning and sterilization validation-related procedures, protocols and technical reports required.
  • Providing product impact and root cause assessments on cleaning and sterilization related events and anticipated changes.
  • Driving improvements in cleaning and sterilization validation.

Areas of Responsibility:

  • Primary source for cleaning and sterilization validation systems knowledge, including experience with Validation of steam in place (SIP) sterilization, autoclave sterilization, dry heat sterilization and sterilizing filtration. Responsible for validation-related activities, such as:
  • Ensure Validation Plans and strategies are in alignment with global policies, procedures and guidelines and external regulatory requirements, and European and International standards.
  • Responsible for Sub-System Ownership for CH35, and provide Support to other Sub-System Owners which overlap in the implementation of changes and system improvements.
  • In partnership with Quality, Sub-System Owners and Technical Operations, develop sterilization re-validation programs, as appropriate.
  • Accountable for compliance of the site sterilization validation program via documentation completion, risk assessments, proactive identification of risks /issues, review of protocols and reports, closure of preventative and corrective actions, and participation in audits and inspections.
  • Participate on investigation teams in the event of adverse sterilization validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem solving skills.
  • Ensure alignment in sterilization validation approaches across the Network, taking an end-to-end viewpoint to ensure successful and reliable product supply.
  • In collaboration with the Product Teams, development groups (e.g. BMSC) and Biotech Technical Operations (BTO) Process Leads, support sterilization validation needs to meet regulatory expectations and supply timelines.
  • Facilitates in problem solving & risk assessment (FMEA) projects/meetings.
  • Develop meaningful validation metrics/trending to enable continued drive for reliability and efficiency.

Qualifications:

  • Academic degree/PHD in life sciences (Biotechnology or related) or comparable level through experience.
  • At least 5 years of validation/ manufacturing experience, in a GMP setting. Preference for experience in biologics manufacturing (cell culture, purification).
  • Proven strong scientific, project & people management skills.
  • Strong communicator and ability to build bridges between groups and organizations. Ability to create a team spirit.
  • Knowledge of GMP guidelines and global validation expectations.
  • Willingness to certify for or possessing Six Sigma Green Belt or Black belt degree.
  • Passion for Lean and Continuous Improvement.
  • Customer focused, process oriented and data driven.

 

If this sounds like your next challenge please send us your CV at pharma@edelway.com

Apply for this job: Senior Validation Engineer

Contact Information:

Address:  Head Office
Sihleggstrasse 23 8832 Wollerau

Switzerland
Tel:  +41 58 717 7000
Website:  Visit Our Web Site

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