Facilities & Maintenance Manager - System One Holdings, LLC

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 appropriatelyprocedures 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.

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