Engineering Change Management Jobs in Raleigh, NC

The Maintenance Coordinator supports the day-to-day execution activities within the assigned function (e.g., Maintenance, Instrumentation & Controls, Utility Operations, etc.) by facilitating work order readiness, ensuring tool and material availability, managing technician workflow, and serving as a liaison between maintenance, production, quality, and other support teams to maintain optimal equipment performance with minimal downtime. This role provides input to maintenance protocols, participates in cross-functional initiatives that drive organizational efficiency, and ensures compliance with Current Good Manufacturing Practice (CGMP), safety, and company procedures. Additionally, this role is aligned to specific shifts or provides rotational coverage, as needed to support maintenance activities across all shifts, ensuring continuity of operations in a 24/7 manufacturing environment.

 What You’ll Do 

•Coordinates, prioritizes, and documents activities of technicians to support uninterrupted production while ensuring clear communication of completed work, delays or outstanding items, safety issues, and cross-departmental coordination for continuity across the site
•Identifies recurring issues by building and participates in or leads root cause analysis and continuous improvement initiatives
•Ensures the availability and procurement of materials, tools, spare parts, permits, and vendors for maintenance tasks and successful work order completion
•Ensures maintenance work complies with CGMP, safety, and documentation standards to promote consistent and standardization of maintenance practices across the site
•Participates in and provides data for audits and regulatory inspections, as needed
•Participates in planned responses (PRs), change management records (CMRs), and engineering change management (ECM), as needed
•Attends daily tier meetings, and tracks equipment availability, status updates, and permit needs across buildings
•Supports equipment maintenance, calibration, qualification, and validation processes
•Helps ensure safety procedures (e.g., Lockout Tagout and confined space entry) are followed
•Supports supervisors with technician dispatch, task prioritization, and onboarding of new personnel (contractors and employees) to the team
•Interfaces with production, quality, and other coordinators to synchronize work activities for continuity, workload balance, and equipment performance and reliability to ensure team achieves key performance indicators (KPIs)
•Revises and implements standard operating procedures (SOPs) and preventative maintenance plans to minimize equipment downtime, as needed
•Participates in or leads cross-functional team initiatives and decision-making processes while building and maintaining positive relationships with internal and external stakeholders
•Assists management with developing comprehensive maintenance workflows, scheduling training for team members, and providing mentorship to technicians
•Monitors projects and tasks to ensure adherence to codes, standards, timelines, and budget requirements while analyzing progress to coordinate timeline adjustments with stakeholders for optimal results
•Provides recommendations to management to develop and refine budget and schedule requirements
•Performs other duties, as assigned

Knowledge & Skills 

•Knowledge of maintenance workflows and equipment fundamentals
•Excellent organizational and communication skills, both written and verbal
•Willingness and ability to inspire and train others to drive team performance
•Detail-oriented, dependable, and responsive in a fast-paced environment
•Proficient with Microsoft Office, and maintenance systems view-only access
•Knowledge of CGMP requirements, safety practices, including LOTO and safe work permitting
•Familiar with Computerized Maintenance Management System (CMMS)
•Ability to develop effective working relationships internally and externally
•Problem-solving and Project Management skills
•Ability to effectively present information to others

Required Skills 

•High school diploma/GED with 4-6 years of experience in project management, planning, or maintenance; or

•Associate degree in engineering or biotechnology field with 2+ years of experience in project management, planning, or maintenance
•4+ years of experience in a GMP pharmaceutical environment
•Prior experience with CMMS and documentation practices

Preferred Skills 

•Bachelor’s degree in mechanical, electrical, or chemical engineering or related field

•6+ years of experience in a GMP environment, showcasing strong familiarity with industry standards and protocols essential for maintaining process integrity
•Experience in project management or lean six sigma

Working Conditions & Physical Requirements:

Will work in environment which may necessitate respiratory protection No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 50 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes