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
