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Facilities & Maintenance Manager

System One Holdings, LLC
Glen, PA Full Time
POSTED ON 4/18/2025
AVAILABLE BEFORE 5/15/2025

Title : Facilities & Maintenance Manager

Type : Direct Hire

Location : Glen Rock, PA 100% Onsite

Schedule : Monday-Friday 8am-5pm

Salary : $120,000- $145,000 Relocation Package and Benefits

Start : Immediate

Responsibilities :

  • Ensures that all Maintenance Associates perform their duties per procedure, per Good Manufacturing Practices, per Good Documentation Practices, and per Safety Policy.
  • Coordinate and supervise maintenance associates to ensure all work activities are completed procedures, cGMP, DEA, and CFR.211 requirements.
  • Review and approve PMs, WOs, and similar records.
  • Organize, coordinate, prioritize and track outstanding issues and opportunities.
  • Coordinate and supervise maintenance associates to ensure support / improvement work is completed procedures, cGMP, DEA, and CFR.211 requirements. Support / improvement work includes but may not be limited to : Deviation investigations, Preventive Actions (PAs), Change Controls, MSOP / PMSOP Biennial reviews.
  • Review and approve deviations and PAs if not executed by self.
  • Initiate and manage facility / project related Change Controls.
  • Formulate potential solutions for discussion with team and manager.
  • Coach and develop maintenance associates. Build the team as necessary.
  • Supply period metrics and updates to Director of Operations to include in period reports.
  • Represent Maintenance department in Change Control, Biennial Review, and other meetings. Assign, execute tasks, and track progress.
  • Provides coordination for and communication within and between all shifts, departments, and levels of the company.
  • Maintain work flow and ensure availability and use of proper materials and tools.
  • Ensures that facilities are clean, controlled, and maintained appropriately procedures and GMP expectations.
  • Analyzes and resolves work problems and coaches associates in resolving work problems.
  • Creates and revises Standard Operating Procedures and Standard Forms process.
  • Collaborates and contributes to the development of new products, processes, and equipment.
  • Lead the implementation and maintenance of LEAN 6S activities within the maintenance unit.
  • Completes performance assessments and on going coaching of operators.
  • Conducts disciplinary action and completes proficiency plans for improvement.
  • As required, perform direct work, demonstrating ability to perform all of the various operations within the department according to documented procedures (QSOP, MSOP, MBR, etc.), protocols, deviations, and training lessons.
  • Ensures compliance with all relevant regulations (e.g. ISO, FDA, OSHA, EPA, DEP, etc.) and company procedures.

Requirements

  • College degree (or equivalent) preferred; relevant experience with equipment and maintenance required.
  • Prior leadership experience (2 years) in a manufacturing environment required.
  • Experienced with FDA-regulated business and requirements necessary to operate in compliance with FDA 21 CFR 211 regulations; familiarity with all stages of pre-clinical and clinical therapeutic offering development.
  • Experience with DEA regulations for handling controlled substances (e.g. Schedules II-V) a plus.
  • Salary : $120,000 - $145,000

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