QSSR-PE-PLANT ENGINEER

Job Title: Plant Engineer 
Department: Engineering & Maintenance
Direct Line Manager: Associate Director, Plant Engineering 
Functional Line Manager: Associate Director, Plant Engineering
Period: January – December 2025


Purpose of the job

Engineering & Maintenance has a mandate to oversee the execution of local preventive maintenance and repair of processing equipment, clean & black utilities, laboratory equipment and facilities at the mRNA-based vaccine manufacturing site. Also, it handles projects, equipment/systems commissioning & qualification, process automation, and calibration in line with cGxP principles. 
The Plant Engineer is responsible for process equipment maintenance planning & execution, troubleshooting & repair, spare parts management, cost control, training, documentation, process optimization, qualification & validation, GMP documents review for process equipment including but not limited to Maintenance Records Change controls, Risk Assessments, Qualification documents and Standard Operating Procedures (SOPs) in quality management systems.

Main responsibilities  

•    Implement the Planned Maintenance system for processing equipment, clean & black utilities, selected Quality Control equipment. 
•    Supervise the day-to-day operation of plant equipment and machinery, ensuring smooth and efficient production processes.
•    Generate and maintain Plant Equipment Maintenance procedures and documents such as but not limited to Risk Assessment, Periodic Requalification Plans, System Impact Assessment etc.
•    Resolve equipment malfunctions and champion RCA to avoid recurrence. 
•    Assess the reliability and performance of critical manufacturing equipment using data-driven approaches and implement strategies focused on improving Overall Equipment Effectiveness (OEE). 
•    Drive continuous improvement to meet world-class manufacturing standards using Operational Excellence principles while continuously developing Engineering best practices. 
•    Ensure timely qualification and re-qualification of equipment at site in line with Qualification Master Plan. 
•    Ensure full functionality of Siemens PCS7 Process Control system for BMS, EMS and MES at the site. 
•    Ensure complete usage of digital applications on site to include COMOS, Beamex CMX, SAP PM, VEEVA among others. 
•    Manage critical spares inventory for all equipment at site. 
•    Maintain up-to-date Engineering documents in eQMS in line with GxP guidelines. 
•    Supporting plant equipment is upgraded projects to ensure successful completion, commissioning and qualification. 
•    Provide necessary guidance to ensure compliance with all applicable external and internal regulations and requirements regarding Quality and EHS in the scope of Engineering. 
•    Implement global best practices and actively share knowledge and lessons learned to contribute and support a high professional level of engineering globally. 
•    Collaborate with Providers, subcontractors and planning firms regarding site’s assets, equipment, systems and maintenance services supervising their activity. 
•    Create / update / review technical documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets) for processing equipment and utilities.
•    Execution of Failure Mode and Effects Analysis (FMEA) to define the maintenance method for each system, evaluation of criticality.
•    Execute DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified Plant Process equipment’s.
•    Coordinate and execute FAT/SAT, commissioning activities for new GMP systems and equipment in collaboration with internal and external partners.
•    Develop and manage budgets for plant operations, maintenance, and capital projects.
•    Implement cost-control measures to optimize expenditure while maintaining effective operations.
•    Interpret installation plans and contract specifications to ensure contract requirements are satisfied.
•    Take a leading role in resolving installation issues, procedures, and methods by working with management, Engineering, Quality Control and Contractors. 
•    Perform installation and commissioning of new equipment and systems within schedule and budget.
•    Manage and support external/internal Qualification team during planning and execution of C&Q activities.
•    Manage Change Controls and Deviations related to all plant equipment on the premises.
•    Collaborate with the local and global Engineering team to define priorities on the C&Q of new equipment as well as process/compliance improvements on existing processes and equipment.
•    Interface with local and global Engineering networks for corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment at site.
•    Collaborate with technical development, other sites, and the global Engineering network to facilitate the transfer of technical knowledge.
•    Mentor and develop Technicians by giving them more complex tasks that require higher levels of understanding of functions.
•    Address Corrective Action Preventive Action issues emanating from internal and regulated GMP inspections.
•    Develop and participate in emergency response plans for potential incidents, ensuring preparedness to handle unexpected situations. 
•    Foster a culture of continuous improvement, encouraging plant personnel to contribute ideas and innovations for enhancing plant efficiency and effectiveness. 
•    Attend and actively participate in all meetings. 
•    Technical report writing. 
•    Any other duties as assigned by the Line Manager.

Work Experience, Skills, and Abilities

Educational level

•    Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering or Biotechnology Engineering.
•    Master’s degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering or Biotechnology Engineering an added advantage.

Professional experiences/Knowledge

•    Minimum 6 years of experience in Plant Engineering or Maintenance Role in the pharmaceutical manufacturing industry.
•    Ability to speak and write the English language fluently.
•    Ability to conduct field inspections including piping and equipment walk downs, operational startup, and troubleshooting.
•    Knowledge of GMP requirements, methodologies, concepts, and requirements related to system validation.
•    FDA – 21 CFR Part 210, 211 Good Manufacturing Practice for Finished Pharmaceuticals.
•    FDA – 21 CFR Part 11 Electronic records and electronic signatures.
•    Knowledge of database software; design software; development software; internet software; spreadsheet software and word processing software.
•    Internal/External team Management to perform all plant related activities. 
•    Excellent planning and organizational skills.
•    Advanced electronics skills with ability to read and accurately interpret schematic diagrams and technical specification documents.
•    Accountability - Ability to accept responsibility and account for his/her actions.
•    Ability to pay attention to the minute details of a project or task. 
•    Ability to make decisions or take actions to solve a problem or reach a goal. 
•    The ability to formulate a sound decision using the available information. 
•    Ability to influence others to perform their jobs effectively and to be responsible for making decisions. 
•    Ability to act calmly under stress and strain.
•    Ability to find a solution for or to deal proactively with work-related problems. 
•    Ability to identify and correct conditions that affect employee safety.

Other requirements 

•    Vision (Near, Distance, Peripheral, Depth Perception) 
•    Sense of touch 
•    Ability to wear Personal Protective Clothing/Equipment (PPC/E) (Safety Glasses, Hard Hats, Safety Shoes, & Safety Harness) 
•    Climb towers with fall protection, work at heights.


Note: The deadline for the application is no later than Friday, December 16th 2024. 
          Only shortlisted candidates will be contacted