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