Principal Maintenance Specialist, Assembly - CVRM (Holly Springs)
$81,400–$151,200 year
HybridHolly Springs, North Carolina, United States
Job Summary
Establish the maintenance program for Assembly equipment during pre-startup, including FAT support and procedure development. Execute planned preventative maintenance, repairs, and troubleshooting for GMP assets post-startup, with specific focus on PLC/automation systems. Partner with Engineering, Quality, and Supply Chain to manage spare parts, BOM improvements, and master data inputs in SAP. Provide coaching and mentorship to facilities personnel while maintaining detailed documentation in electronic and paper systems. Transition from remote and construction site work to full-time on-site operations, adhering to cGMP, safety standards, and controlled environment protocols.
Required Qualifications
- High School diploma or equivalent
- 7+ years of related work experience in an industrial / manufacturing setting
- demonstrated strong mechanical aptitude
- experience with maintaining a medical device assembly line
- ability to organize and solve complex, unique or unprecedented problems
- proficiency in using AI and other digital tools to solve complex challenges
- familiarity with cGMP's
- familiarity with Health Authority regulations
- familiarity with Quality Systems
- Strong interpersonal skills
- Strong communication skills (written and verbal)
- project management skills
- time management skills
- Active role which includes lifting up to 35 lbs
- navigating stairs/ladders/scaffolding
- transporting equipment to the location of instruments
- working away from a desk for the majority of working shift
- Be able to work extensive hours while standing
- Travel of up to 30% of the time
- flexible working hours including overtime or on-call
- Read and Understand P&lDs
- work from Standard Operating Procedures (SOPs)
- basic computer skills using word processors, spreadsheets, databases, and email
- provide inputs to master data needed to support the maintenance program in SAP S4/HANA
- Proficient in Quality Management System(s)
- understand controlled, classified environments
- understand aseptic processing principles
- maintain associated qualifications for access
Desired Qualifications
- An A.A., A.S., A.A.S., or Trade School Certificate
- 5+ years of related work experience
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