AbbVie Operations Singapore Pte Ltd
Senior/Engineer - Utilities
Job Nature : Perm
Position Level : Experienced
Qualification : Diploma,Bachelor's / Honours,Masters / PhD
- Owns and is responsible for overseeing the Operation and Maintenance of GMP Utility systems like Purified Water, WFI, Clean Steam.
- Supervise contractors and external workers in addition to Abbvie utilities personnel.
- Responsible for the performance of preventative & repair maintenance of the GMP utility system equipment, periodic inspections of utility systems to ensure proper operation, and daily checks/repairs in compliance with Standard Operating Procedures (SOPs).
- Analyze trends and identify issues and improvement opportunities proactively on these critical systems.
- Report to the Utilities Manager
- Provide operational and maintenance support for the successful and uninterrupted operation of GMP Utility systems like Purified Water, WFI, Clean Steam in API and Biotech plants
- Responsible for other utility systems like Clean gases and waste treatment/ disposal facilities.
- To provide support to ongoing plant operations on a 24 x 7 basis and ensure total compliance to cGMP and safety standards
- Develop Operation, Maintenance and monitoring regimes and play a key role in improving manufacturing success rates, maintaining compliance, providing for a safe work environment and controlling costs of the manufacturing operations
- Supervise contractors, engineers and technicians and provide day to day operational support and maintenance services including, modifications and changes to processes and equipment, troubleshooting, deviation investigation, identification and completion of corrective and preventative actions
- Oversee the day to day operations and routine / breakdown maintenance of the GMP Utility systems
- Maintain records to comply with Good Manufacturing Practice requirements
- Take ownership of utility systems and as the Subject Matter Expert, front regulatory and other audits
- Manage contractors and vendors to ensure equipment is maintained in full operational status
- Ensure prompt response to maintenance calls and emergencies,utilities outage and breakdowns
- Perform system evaluations and performance reports to ensure all utility equipment is operating efficiently and down time is limited to scheduled maintenance
- Analyze technical problems in the utility and manufacturing areas and develop both short term and long term recommendations for their correction. Lead or assist cross-functional teams in finding solutions to technical problems
- Assist in the execution of Process Change Controls and responses to CAPAs
- Execute Installation Qualification (IQ) on plant and process equipment and systems
- Assist Validation with execution of various validation protocols
- Actively engaged in developing specifications for equipment and utility systems and assist in FAT / SAT of related equipment as part of the new build-outs
- Any other duties as assigned by your Supervisor/Manager
- Bachelor’s degree or a diploma in Engineering
- At least 10 years of relevant work experience
- Knowledge of cGMP is highly preferred
- Working experience in a pharmaceutical / biotech facility
- Hands-on experience in start-ups, commissioning & qualification of utility systems is a plus
- Excellent leadership and communication skills
- Ability to lead teams including external contractors
- Mentoring and coaching skills
- Excellent team player willing to work for the common goal