
High-Performance Site Maintenance Specialist
2 days ago
We are seeking a highly skilled and experienced Senior Facilities Engineer to join our team in a manufacturing environment.
The successful candidate will be responsible for maintaining the highest cGMP standards, ensuring the smooth operation of plant and facility equipment, and contributing to ongoing and future site development projects.
Key Responsibilities:
- Report to the Facilities Manager and work closely with the site Facilities Team
- Analyse and investigate general facilities/maintenance issues, preparing and compiling written reports for the Facilities Manager
- Ensure HVAC, compressors, chilled water, and general site services operate to required cGMP standards
- Assist with installation and setup of new production cells and services, including validation in conjunction with Quality
- Work closely with the HSE Manager to identify and address all health, safety, and environmental issues on the site
- Manage facility maintenance systems to in-house quality compliance standards, including ISO 9001/ISO 13485, ISO 14001, and OHSAS 18001
- Liaise with the Quality/Compliance Department regarding room/facility qualifications and required documentation
- Support and participate in Quality Risk Assessments related to facility design and qualification
- Actively participate in and comply with all West HSE programs and regulations
- Maintain a neat and orderly work environment according to the West 6S program
Requirements:
- Degree in Facilities or Mechanical Engineering or related discipline
- Minimum 10 years working within a high-volume manufacturing environment
- Additional Trades Qualification is an advantage
Physical Requirements:
- Medium-exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects
Preferred Knowledge, Skills, and Abilities:
- In-depth knowledge of plant systems preferably in the pharmaceutical/medical device industry
- Proven experience in the qualification, operation, and maintenance of Grade C (or higher) cleanrooms
- Working knowledge of AHU/HVAC, chilled water, compressed air, dryers, and electrical systems
- Ability to read electrical, hydraulic, and pneumatic schematic diagrams/P&IDs
- Proficient in asset management ensuring maintenance of the validated state of plant and equipment
- Experience of working in an EU GMP controlled environment
- Experience in cold storage facility maintenance and drug handling is essential
- Ability to negotiate annual SLAs for plant critical equipment and support systems
- Act as site SME for site CMMS and equipment uptime
- Act as the point of contact for vendors and contractors
- Familiarity with SAP, Master Control or similar systems and databases is a plus
Travel Requirements:
- 5%: Up to 13 business days per year
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