Quality Engineering Specialist

Manpower Switzerland is a leading provider of job placement services, helping over 20,000 men and women find permanent or temporary positions each year. With a network of over 5,000 client companies, ranging from SME's to multinationals, Manpower connects talented individuals with opportunities in various industries. The company is dedicated to providing high-quality services and is committed to supporting professional development and career growth.

Role Description

This is a temporary, on-site role located in Stein for a Quality Engineering Specialist.

Duration: from 22/04/2024 to 31/03/2025 (with extension possibility)

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