Associate Director, GMP Maintenance & Reliability

FUJIFILM Electronic Materials (Europe) N.V.

Holly Springs (NC)

On-site

USD 150,000 - 190,000

Full time

4 days ago

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Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks Associate/Director, Maintenance to lead the site maintenance organization with end-to-end accountability for equipment, reliability, spare parts, and MRO. The role builds a GMP-compliant, inspection-ready maintenance program supporting large-scale biologics manufacturing and site ramp-up.

As the senior maintenance leader, you will partner with Manufacturing, Quality, Validation, and EHS to balance availability, compliance, and cost while

Qualifications

8–10+ years in a maintenance leadership role in pharma/biotech.
Experience leading 40+ personnel and cross-functional teams.
Proven experience with CGMP and 21 CFR 211.67, Part 11.
Proficient CMMS implementation and maintenance program governance.
Strong budget, safety, and EHS alignment.

Responsibilities

Lead site maintenance organization and ensure GMP-compliant program.
Govern CMMS data integrity and spare parts management.
Develop ramp-up and hiring plans for commercial operation.
Oversee external maintenance providers and OEMs.
Report maintenance KPIs and lead business reviews.
Ensure 24/7 readiness.

Skills

People leadership

Team development

Cross-functional collaboration

Communication

CGMP knowledge

CMMS knowledge

Reliability engineering

Budget management

Risk-based decision making

Education

Bachelor's degree in life science or engineering

Master's degree in life science or engineering

Tools

CMMS (SAP/Maximo)

Job description

As the senior maintenance leader, you will partner with Manufacturing, Quality, Validation, and EHS to balance availability, compliance, and cost while

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