Reports to : Senior Manager, Facilities and Engineering
Facilities Engineer
Reports to : Senior Manager, Facilities and Engineering
Objectives
Design and implement the Utilities and Facilities used in Biologics manufacturing operations.
Support, manage and coordinate all engineering related matters & infrastructure.
Develop a strong relationship with stakeholders, understanding their requirements & difficulties to provide solutions
Highly in dependable, efficient, knowledgeable, and competent in all aspect of engineering scopes.
Lead in the team/services responsible for a smooth operation and maintenance of the systems, equipment and processes comply with cGMP, EHS and GEP requirement to business expectation.
Responsibilities:
Responsible and manage the operation and maintenance of systems (Utilities, Electrical, HVAC, Cleanroom) to provide the required level of availability.
Ensure all systems operate smoothly and delivers the required level of reliability, availability, and quality.
System
Cooling/Chilled water distribution
Hot water and distribution system
Steam boiler
Air compressor and distribution system
Waste collection and waste treatment
Clean utility: Pre-treatment, Purified water, Water For Injection, Technical Gases
Electrical genset, switchboards and power distribution.
HVAC, Cleanrooms, etc.
Manage teams/services to develop, implement and execute maintenance programs using CMMS with best practices in a safe and cost-effective manner and in compliance with requirements.
Support Projects, Capex & Engineering change modification, automation, validation, quality related matters.
Ensure system meet user’s requirement with plan, control and monitor project schedule with resource and procurement planning.
Provide support in submission and obtaining the approval of required local permits / license for new engineering project / Modification installation
Participate in the design and validation (IQ, OQ, PQ) of all relevant systems (Black and Clean utilities, HVAC, Cleanrooms, BMS, EMS, etc)
First point of contact as Subject Matter Expert (SME) for assigned system related subjects in the supported business function.
Contribute to the definition and incorporation of Good Manufacturing Practise in a manufacturing environment including the creation of Standard Operating Procedures capitalizing on Utilities and facilities systems.
Experience in sites for Deviation, CAPA, Root cause analysis and Change Control Management.
Education, Behavioral Competencies and Skills:
Degree in relevant engineering field or Diploma with relevant engineering experience.
At least 8 years of technical experience in Life Sciences/Bio/Pharma industry with at least 2 years of supervisory experience.
Knowledgeable and competent in their field of work on Utilities and Facilities.
Strong technical knowledge and well verse in all technical aspects
Demonstrate excellent GMP behaviour and safe practices
Excellent troubleshooting and analytical skill in investigation
Experience leading and managing large projects on utilities and facilities.
Team player with proven performance records, creative thinking abilities, and excellent interpersonal and communication skills.
