Operations Support Engineer, Drug Product
The Operations Support Engineer
The Operations Support Engineer will support the startup of a state-of-the-art aseptic manufacturing facility with multiple production lines. Reporting to the Department Head of Commercial DP, this role focuses on supporting operational readiness for aseptic manufacturing, including documentation, training coordination, and site systems setup (e.g., SOP/MBR/WI preparation, logbooks, environmental and utilities sampling).
You will work closely with cross-functional teams such as MSAT, Validation, Quality, and QC to ensure smooth execution of New Product Introduction (NPI), technology transfer, and process validation activities. This role provides strong exposure to startup operations, regulatory requirements, and aseptic manufacturing processes.
Responsibilities:
- Support installation, commissioning and qualification of manufacturing equipment from an operational readiness perspective.
- Assist in preparation and maintenance of operational documents, including SOPs, Master Batch Records (MBRs) and Work Instructions (WIs)
- Coordinate with service providers and contractors (e.g., cleaning/disinfection, gowning laundry) to ensure readiness and compliance
- Support execution of environmental and utilities monitoring activities in accordance with procedures
- Assist in onboarding and coordinating training for manufacturing personnel
- Track training completion and support qualification of operations staff
- Provide support during system go-live and initial manufacturing phases
- Ensure compliance with cGMP and internal quality standards during startup and routine operations
- Work closely with MSAT, Validation, QA and QC teams to support NPI, technology transfer and validation activities
- Support audit and inspection readiness activities (e.g., documentation, mock inspections)
- Utilize QMS systems (e.g, Change Control, Deviation, CAPA) under guidance
- Participate in deviation investigations and root cause analysis (e.g., 5 Whys, Fishbone)
- Interface with internal stakeholders and support client related activities when required
- Support site readiness timelines and operational milestones
- Perform other duties as assigned during startup phase
Requirements:
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or any related field
- Minimally 5 years in drug product manufacturing, with experience in operational support
- Experience with DP shopfloor experience (across various operations) will be at advantage