Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
The Lead Engineer is responsible for cGMP compliance, end-to-end C&Q responsibility (with partners) on assigned Capex projects, support divisions on technology transfer and new product launches to important market and support divisions on auditing (Bayer sites and CMO sites) in APAC region as well as drive aspiration and passion to ensure safe, reliable and sustainable technology solutions for Bayer’s Life Science Businesses– today and tomorrow
YOUR TASKS AND RESPONSIBILITIES:
- Lead Commissioning, Qualification and Validation for facilities,utilities and pharmaceutical manufacturing equipment, formulation, filling and packaging systems with full cGMP compliance.
- Conduct Process FMEA and incorporate the system functions in process equipment.
- Write and review URS, conduct risk assessment and to follow-up with TM, FAT, SAT, IQ, OQ, PQ, VMP with internal and external resources.
- Experience in Technology transfer and Process Performance Qualification (PPQ) for new process, Technology introduced to manufacturing site.
- Knowledge in computerized system and use of digitalization in Pharmaceutical processes. performed CSV accordance to EU GMP Annex 11and 21 CFR Part 11.
- Coordinate with various stake holders to establish and achieve common objectives without compromising KPI (Quality, Cost and Schedule).
WHO YOU ARE:
- Bachelor/Master degree in Engineering, Technology
- More than 5 years of experience in Pharmaceutical industries in Project Engineering/Manufacturing Engineering/Quality Engineering.
- Experience in Project Management skills.
- Customer-focus, Value difference, Self-development, Builds effective team
- Ability to work in different geographic locations.
- Willingness to execute projects at remote locations under travel or project assignment across Asia Pacific region
Reference Code: 183407
Functional Area: Engineering & Technology