Spclst, Engineering
Merck
4 hours ago
On-site
West Point, PA
Operations
Responsibilities:
- Provide maintenance staff support for all scheduled work associated with designated equipment
- Schedule equipment calibrations and preventative maintenance
- Conduct equipment Lock Out / Tag Out
- Manage qualified equipment inventories
- Support equipment validation activities
- Author, review, and approve change management documentation
- Provide engineering guidance for equipment upsets and events
- Ensure GMP status of equipment and facilities
- Conduct Equipment Qualification Periodic Review for designated equipment
- Create equipment and facility work notifications for corrective maintenance
- Maintain/manage equipment parts lists for designated equipment; order special parts and manage small parts/accessories
- Lead small capital projects
- Evaluate new technologies and equipment for potential use
- Support environmental and safety initiatives
Qualifications / Required Experience:
- Bachelor’s degree in Engineering with minimum 3 years of relevant experience OR Master’s degree in Engineering
- Candidates with a degree in a non-technical discipline plus relevant experience in pharmaceutical/biologics equipment management considered in lieu of a formal engineering degree
- Previous experience supporting equipment and/or GMP manufacturing facilities, or laboratory areas
- Strong teamwork and collaboration
- Extensive knowledge of cGMP, Quality Systems, and equipment safety
- Highly self-motivated; ability to work in a fast-paced, dynamic setting
Preferred Experience / Skills:
- Excellent organizational, problem-solving, and project management skills
- Strong technical background on pharmaceutical production equipment
- Experience working on teams in a matrixed organization
Required Skills:
- cGMP compliance; GMP compliance; change control processes
- Regulatory compliance; computerized maintenance management systems (CMMS)
- Equipment maintenance; maintenance processes; maintenance supervision
- Asset inventory management; calibration management software
- Process control; automation systems; electrical systems; mechanical systems
- Environmental health and safety; data analysis; detail-oriented
Work Requirements:
- Understanding of regulatory guidelines governing GMP operations
- Work collaboratively with plant personnel, EM&U, Quality, environmental, and safety groups
- Some overtime (including weekends) and occasionally supporting off-hour manufacturing
Application:
- Apply through https://jobs.merck.com/us/en (deadline stated on the posting).
- Provide maintenance staff support for all scheduled work associated with designated equipment
- Schedule equipment calibrations and preventative maintenance
- Conduct equipment Lock Out / Tag Out
- Manage qualified equipment inventories
- Support equipment validation activities
- Author, review, and approve change management documentation
- Provide engineering guidance for equipment upsets and events
- Ensure GMP status of equipment and facilities
- Conduct Equipment Qualification Periodic Review for designated equipment
- Create equipment and facility work notifications for corrective maintenance
- Maintain/manage equipment parts lists for designated equipment; order special parts and manage small parts/accessories
- Lead small capital projects
- Evaluate new technologies and equipment for potential use
- Support environmental and safety initiatives
Qualifications / Required Experience:
- Bachelor’s degree in Engineering with minimum 3 years of relevant experience OR Master’s degree in Engineering
- Candidates with a degree in a non-technical discipline plus relevant experience in pharmaceutical/biologics equipment management considered in lieu of a formal engineering degree
- Previous experience supporting equipment and/or GMP manufacturing facilities, or laboratory areas
- Strong teamwork and collaboration
- Extensive knowledge of cGMP, Quality Systems, and equipment safety
- Highly self-motivated; ability to work in a fast-paced, dynamic setting
Preferred Experience / Skills:
- Excellent organizational, problem-solving, and project management skills
- Strong technical background on pharmaceutical production equipment
- Experience working on teams in a matrixed organization
Required Skills:
- cGMP compliance; GMP compliance; change control processes
- Regulatory compliance; computerized maintenance management systems (CMMS)
- Equipment maintenance; maintenance processes; maintenance supervision
- Asset inventory management; calibration management software
- Process control; automation systems; electrical systems; mechanical systems
- Environmental health and safety; data analysis; detail-oriented
Work Requirements:
- Understanding of regulatory guidelines governing GMP operations
- Work collaboratively with plant personnel, EM&U, Quality, environmental, and safety groups
- Some overtime (including weekends) and occasionally supporting off-hour manufacturing
Application:
- Apply through https://jobs.merck.com/us/en (deadline stated on the posting).