Engineer, Facility and Engineering
3 days ago
**OBJECTIVES**:
- Develop and implement systems for 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, Process Equipment) 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
- Air compressor and distribution system, Compressed Gases, CCTV, BMS/ EMS
- Waste collection and waste treatment (Process Waste, Bio Waste)
- Clean utility: Type 1 Ultrapure water system and Technical Gases (O2, Co2, N2)
- 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 validation (IQ, OQ, PQ) of all relevant systems (Black and Clean utilities, HVAC, Cleanrooms, BMS, EMS, etc)
- 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.
- Support Cross functional department such as Automation on routine back up, trending and any other activities, Technical Services on periodic qualification, Supply chain and Manufacturing on process equipment maintenance.
**EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS**:
- Degree in relevant engineering field or Diploma with relevant engineering experience.
- At least 2 years of technical experience in Life Sciences/Bio/Pharma industry 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.
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