Key Responsibilities
- Head a team of engineers and technicians in managing maintenance and calibration of aseptic Drug Product and Drug Substance facility.
- Lead the team in maintaining Drug Product clean room, Pre-filled syringes lines, vials lines with lyophilizer, automatic inspection machines. Ability to maintain the lyopillizers and its associated system with high operation efficiencies. (High OEE with minimum downtime)
- Lead the team in maintaining Drug Substance facility clean room, hybrid solution preparation systems in optimum operating efficiencies. (High OEE with minimum downtime)
- Support Global Engineering Team and Validation/Operation team in the project design review, selection of equipment, testing/commissioning and IOPQ support.
- Author, review, approve documents, URS, FRS and protocols related to process Engineering and both maintenance and calibration strategies for both DP and DS facilities.
- Collaboration with team members of Central Utilities and planning/scheduling team in organizing efficient implementation of DP/DS maintenance and calibration.
- Lead team in Failure mode analysis, deviation reporting and CAPA resolution and CAPA effectiveness monitoring.
- Operation and Maintenance of Clean Utilities (CU and Equipment- PFW, WFI and it’s distribution loop), including URS preparation, review and approval, bidding process, packages delivery, site installation, commissioning and qualification support
- Support project management team or managing EPCM on project execution
- Take leading role in Process Engineering operation readiness and start up preparation including SOPs, PM system, Calibration system, routine inspection, technical authority, special equipment management, energy management, engineering maintenance budget, engineering compliance etc
- Introduce predictive operation and maintenance strategy to raise the standards of reliability engineering to world class standards. (Reliability Engineering Standards)
- Drive and lead in Process Engineering team in continuous improvement program, machine learning or computer system aided maintenance (Predictive or condition monitoring via either AI or machine learning methodologies).
- Support strategic planning for facilities expansion.
- Be responsible for working with government agencies in engineering related matters.
- As Process lead, be responsible and an integrator for the department to establish teamworking culture with other department staff, including promotion of HR “Passion To Work’ initiatives.
- Host client and authority inspection and audit on engineering aspects.
- Implement knowledge management to upgrade skills and capabilities of staff in the Process engineering team.
- Be responsible for EHS and Quality compliance for the department.
- Other ad hoc project or tasks as required.
Requirements
Education level
(Education level + professional requirements)
- Bachelor or above degree in Engineering.
Work experience
(years / professional experience / industry experience / management experience)
- > 15 years in Engineering roles preferably 5 years at Senior management level.
- > 10 years in Pharmaceutical aseptic Drug product filling and Drug substance manufacturing.
- Prior experience in Greenfield project preferred.
Professional knowledge & Capability requirements & Accountability
- Good knowledge at GMP and associated Biologics regulatory guidance’s. (FDA/ICH/PIC’s and WHO guidelines)
- Lean concept and knowledge preferred
- Fluent English (written and spoken). Fluent Chinese (spoken) preferred;
- Engineering, system, process, compliance, people management, leadership and continuous improvement.