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.

  #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.