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West Pharma Senior Facilities Engineer Manufacturing Ireland, Dublin 990392464
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Essential Duties and Responsibilities
- Report to the Facilities Manager.
- Analyse and investigate general facilities/maintenance issues, preparing and compiling written reports for the Facilities Manager with solutions and recommendations.
- Ensure HVAC, compressors, chilled water and general site services are operating to the required cGMP standards.
- Assist with the installation and set-up of new production cells and services to include validation in conjunction with Quality.
- Work closely with the HSE Manager to identify and address all health, safety and environmental issues on the site.
- Management of facility maintenance systems to in-house quality compliance standards i.e. Quality Systems ISO 9001/ISO 13485 and Environmental Management Systems ISO 14001 & OHSAS 18001.
- Liaise with the Quality/Compliance Department with respect to room/facility qualifications and required documentation.
- Support and participate in Quality Risk Assessments with respect to facility design and qualification.
- Actively participate and comply with all West HSE programs and regulations.
- Maintain a neat and orderly work environment in accordance with West 6S program.
- Other duties as assigned.
Education
- Degree (Level 8) in Facilities or Mechanical Engineering or related discipline.
- Additional Trades Qualification is an advantage.
Work Experience
- Minimum of 10 years working within a high-volume manufacturing environment.
Additional Requirements
- While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
- Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
- The ability to be able to lift and carry various items up to 40 pounds.
- The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
- The employee occasionally works near moving mechanical parts and or equipment.
- The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
- Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.
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 SLA's 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.
- Must be familiar with computers and various software programs.
- Familiarity with SAP, Master Control or similar systems and databases, a plus.
- Excellent communication and interpersonal skills.
- Good analytical skills.
- Ability to work both independently with little direction, and as a member of a team.
- Ability to manage several projects at once to meet established timelines is essential.
- Some understanding of the injection moulding process is desired.
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.
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