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Production Maintenance Senior/Principal Engineer
2 weeks ago
Production Maintenance Senior/Principal Engineer
Summary: This role ensures Drug Product (DP) and Drug Substance (DS) process equipment for commercial scale manufacturing operations performs optimally for long-term manufacturing success. The role will collaborate cross-functionally, troubleshoot technical challenges, and drive innovative solutions to enhance production efficiency and equipment reliability, while maintaining compliance with industry regulations and GMP standards.
During Project stage, the Production Equipment Engineer is a key contributor to the design, installation, commissioning, and qualification of process equipment for large-scale biopharmaceutical projects. This role ensures seamless equipment integration from project execution to operational readiness.
Responsibilities
Operational Phase (Primary Role)
Oversee and improve ongoing maintenance and operational reliability of DP and DS process equipment.
Implement asset management systems to track maintenance schedules, spare parts, and costs.
Ensure all equipment requiring statutory inspections are scheduled and tracked in CMMS systems (e.g., Maximo).
Train maintenance teams on new procedures, troubleshooting, and safety protocols.
Set up and maintain a maintenance workshop equipped with the necessary tools and procedures.
Regularly review maintenance data to identify areas for process improvement and cost reduction.
Establish protocols for handling downtime, emergency maintenance, and system failures promptly.
Support continuous improvement initiatives and implement design enhancements based on operational feedback.
Maintain strict compliance with GMP standards and safety regulations, ensuring no significant findings during inspections.
Facilitate the transition from project completion to full operational status, ensuring a seamless handover.
Project Phase (Initial Role)
Provide technical expertise during the design phase to ensure equipment meets all operational requirements including performance, maintenance, and reliability.
Collaborate with design team and vendors to establish maintenance strategies, spares availability, and service contracts.
Develop and maintain engineering documentation (e.g., equipment specifications, preferred vendor lists, P&IDs, equipment layouts).
Support technical evaluation during procurement stage by reviewing equipment data sheets, P&IDs, and technical requirements.
Lead the development of bidding documents, vendor evaluations, and bidding processes as package owner.
Participate in key commissioning activities including system checks, lubrication, alignment, and performance testing to ensure equipment meets operational standards.
Work closely with QA and Qualification teams to review commissioning and qualification documentation.
Troubleshoot and resolve commissioning issues and discrepancies.
Support or execute qualification tests and inspections according to approved protocols. Document qualification results and deviations, and ensure compliance with validation requirements.
Review qualification reports and support final approval processes.
Conduct technical inspections to support handover, ensuring system functionality and compliance.
Requirements
Education level:
Bachelor degree
in mechanical engineering, mechatronics or related
Minimum 8 years of experience in process equipment engineering within biopharmaceutical, pharmaceutical, or biotech manufacturing.
Principal Engineer: Minimum 12 years of relevant experience with demonstrated expertise in large-scale equipment integration.
Hands-on experience with bioreactors, chromatography skids, ultrafiltration systems, CIP skids, DP filling lines, Lyophilizers, automated visual inspection machines and other DP/DS process equipment is highly desirable.
Professional knowledge & Capability requirements & Accountability
Strong understanding of GMP, biopharmaceutical manufacturing processes, and equipment validation.
Experience managing multiple priorities and delivering high-quality results within tight deadlines.
Mechanical and production equipment experiences in Biotech or production with understanding of mechanical principles, components, and systems related to production equipment such as agitators, motors, pumps, conveyors, gears, mechanical seals and bearings etc.
Familiar with computerized maintenance system (e.g. Maximo or others).
Ability to diagnose equipment malfunctions, analyze root causes of failures, implement corrective actions, and optimize equipment performance through continuous improvement initiatives.
Ability to work under pressure, assertiveness, fast decision making, high flexibility.
Demonstrated ability to engage with internal and/or external auditors on production equipment matters and ensure prompt follow-up on CAPA actions post-audit.
Other Special Requirements
Proficient in office productivity tools, AutoCAD, and other relevant engineering software used for design, documentation, and analysis.
Exhibit self-initiative, independence, and a goal-oriented mindset, taking ownership of tasks from design through to operational readiness.
Possess strong collaboration and communication skills, with the ability to work effectively across teams and be open to short-term business travel, both domestically and internationally.
Willing to attend a minimum of 3 months of training in China, as required for project alignment and knowledge
