A service provider leading the Pharmaceutical and Medical Device sectors since 1998. A Company that is constantly growing and has over 2000 employees worldwide.
Roles and Responsibilities
You will be expected to provide support in site process engineering, installation verification, pre-commissioning, SAT, and commissioning of equipment/utilities/ancillaries, used in biotech facilities.
Follow standard operating procedures and standards in a highly regulated environment
Generate and execute procedures/protocols through GMP verification process
Adhere to safe work practices
Clearly communicate progress and issues to management and peers and finalize report writing for test protocols
Perform all tasks in strict compliance with operating procedures, best practices, and regulatory requirements
Accountable for accurately completing GMP documentation
Candidate Requirements
Chemical Engineering master degree
At least 3 years related process engineering design experience, with preferred experience in biotech, with understanding of automated process equipment, systems architecture and operations, and related components
Knowledge of cGMPs and main pharmaceutical standards and rules
Knowledge of process control and P&IDs standard settings and ISA standard symbology
Knowledge of safety current rules for equipment/plants design and attention to health and safety practices within the working environment
Previous experience in equipment and process and equipment validation is helpful, but not just focusing on this
Technical expertise in GMP biotech processes that include upstream & downstream manufacturing and clean utilities