Maintenance Engineer - Drug Product - Malaysia Employment

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Roles and Responsibilities

- Preparation, review and closure of QMS elements (CAPA, Change management, Deviation, PM, Communication Memo)

- Preparation/review of qualification documents, validation, PM planner, memos, training materials

- Support FAT/SAT/DQ/IQ/OQ/PQ activities

- Generate/support required documents

- Managing shift operations effectively

- Taking accountability for all shift activities

- Working in shifts and supporting operations during critical breakdowns

- Execute planned preventive maintenance to achieve zero unplanned downtime

- Raise preventive maintenance communication memo

- Maintain spare part availability

- Perform planned/unplanned maintenance

- Detect unusual equipment conditions proactively

- Ensure equipment operation per manufacturer recommendation

- Report daily activities and issues

- Support FAT/SAT/DQ/IQ/OQ/PQ

- Conduct required trainings

- Fill log sheets/checklists/history cards

- Participate in audits and close findings

- Prepare shift scheduling

- Issue work permits/gate pass

- Attend mandatory GMP/GDP/GLP/Data Integrity/Microbiology training

- Ensure documentation accuracy per ALCOA principles

- Coordinate document control procedures

- Maintain updated registers and controlled documents

- Review and update technical documents

- Ensure smooth internal/external audits

- Track QMS elements and overdue items

- Support FAT/SAT/DQ/IQ/OQ/PQ activities.

Skills Required
Preventive Maintenance, Gmp, Capa, Glp, Sat, data integrity, IQ, OQ, Microbiology, Change Management