Summary
In this role, you will be driving both production excellence and digital transformation, this role combines hands-on Upstream GMP manufacturing with Automation SME leadership. You will partner with cross-functional teams to design and deploy MES and PCS (Delta V/Unicorn) solutions, ensuring a seamless transition from facility setup to live operations
Department : Commercial Drug Substance (DS) Manufacturing
Responsibilities :
- Represent Manufacturing team as key contact person to work with Automation team on process related designs technical standards.
- Support new facility design and validation with focus on integration of process equipment and MES (Electronic Batch Record) into mainframe control systems (PCS, OT etc.).
- Involve or review design and commissioning documents (FS, FAT/SAT, IQ/OQ protocols etc.) to ensure process equipment integration requirements are in place and validated.
- Involve in key process equipment FATs and ensure the integration design and successfully tested.
- Act as automation SME that support routine manufacturing activities, including process set up and troubleshooting.
- Responsible for instrument preparation, cell expansion, cell culture, depth filtration and other process operation per GMP requirement. Perform aseptic operation in BSC such as vial thawing.
- Responsible for EM monitoring as authorized by QC team.
- Responsible for cleaning in the clean area per GMP requirement, such as periodic cleaning, changeover cleaning and equipment cleaning, etc.
- Responsible for the drafting/revision of SOP/MBR/URS/FAT/SAT and other documents
- Participate in the deviation investigation, implementation of relevant changes as well as audit and rectification activities.
- Ensure individual GMP trainings are completed on time.
- Perform any other duties as assigned by your Lead/ Manager.
- 12-hour rotation shift is required
Requirement
- Bachelor degree in Chemical/Biochemical Engineering, Generic Engineering, Biochemistry, Automation (preferred), Electrical& Instrument
- Strong knowledge of automation, with relevant work experience in a similar manufacturing industry or cleanroom environment preferred.
- Knowledge about MES, PCS (Delta V, Unicorn) etc. in production plants is preferred
- Strong coordination and interpersonal skills. Able to work cross-department and work with multi-discipline to drive project to success.
- Good knowledge on GMP, 21 CFR Part 11 and EU Annex11 regulation and requirement.
- Positive team-oriented demeanor.
- Self-motivated, quick paced with flexibility to meet aggressive timeline.
- Overseas Training may require
