LSC has a fantastic opportunity for a C&Q Lead Engineer to join an advanced global team in Czechia that promotes self-development, encourages collaboration, and fosters a learning environment. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Commissioning Execution: Oversee the commissioning of systems and equipment to ensure they meet specified requirements and are operationally ready.
- Qualification Documentation: Develop and maintain comprehensive qualification documentation, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ) based on FAT protocols delivered by the respective WPOs and the suppliers, Operational Qualification (OQ) based on SAT protocols & I/O checks delivered by the respective WPOs and the suppliers, and Performance Qualification (PQ) where applicable and necessary.
- Compliance Assurance: Ensure all C&Q activities comply with regulatory guidelines and industry standards. Ensure all C&Q activities are performed according to the quality system (PQMP).
Experience and Qualifications:
- Bachelor's or Master's degree in Pharma Technology, Process Engineering, Biotechnology, or related field.
- 5+ years of experience in commissioning & qualification within the pharmaceutical industry, preferably within any related mammalian production area.
- Strong knowledge of GMP, and qualification lifecycle documentation.
- Proficiency in project management tools and methodologies
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold an EU/UK Passport to apply! Apply via this advert or contact Stephen Abdullah at +353 214777329 if you have any more questions about this opportunity!
