QA Validation Engineer

The role:

PE Global is currently recruiting for a QA Validation Engineer on behalf of a leading pharmaceutical company based in Stein, Switzerland. This is an initial 12-month contract role.

Description:

This is a QA Qualification Capex role within the Quality Engineering Unit and will support the Project Team for the fill-finish aseptic facility project in Stein (Switzerland, AG), and the incumbent will be responsible for the lyo line from DQ to OQ.

Key responsibilities:

• Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
• Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
• Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
• Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
• Providing leadership and guidance to project team members on C&Q strategy and issues
• Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
• Escalating issues in an open and timely manner and take leadership for their resolution

Key requirements:

• Bachelor or Master’s degree in Engineering, Life Sciences or related field
• Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
• Experience in a QA role for the C&Q of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
• Fluent in English, German would be an advantage

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***