ARx Facilities and Engineering Manager

Job Summary:

The ARx Facilities & Engineering Manager is responsible for the general oversight and supervision of all ARx Facilities and Maintenance including plant, property, and all machinery and equipment consistent with cGMP for Pharmaceutical manufacturing under CFR211 guidelines. This role ensures the reliability, compliance and efficiency of manufacturing and utility systems. The Facilities Maintenance Manager is a proactive leader with a strong technical background, experience in project management and commitment to operational excellence.

Essential Functions:

• Ensure the maintenance, repair and optimal operation of the facility, including HVAC system, plumbing, electrical, USP water and building monitoring systems.
• Develop and implement preventative maintenance programs for critical systems to ensure continuous operation.
• Coordinate with vendors and contractors for facility upgrades, repairs, and routine services as needed.
• Ensure that all ARx Maintenance associates perform their duties per procedure, per Good Manufacturing Practices, per Good Documentation Practices, and per ARx Safety policies.
• Coordinate and supervise Maintenance associates to ensure all work, activities, and support/improvement work is completed per ARx procedures, cGMP, DEA, and CFR.211 requirements. Support/improvement work includes, but is not limited to: deviation investigations, preventive actions (PAs), change controls, MSOP/PMSOP biennial reviews.
• Review and approve PMs, WOs, and similar records.
• Organize, coordinate, prioritize and track outstanding issues and opportunities.
• Review and approve deviations and PAs if not executed by self.
• Initiate and manage facility/project related change controls.
• Parato the maintenance and facility issues and 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.
• Provide coordination for and communication within and between all shifts, departments, and levels of the company.
• Maintain workflow and ensure availability and use of proper materials and tools.
• Ensure that the ARx facilities are clean, controlled, and maintained appropriately per ARx procedures and GMP expectations.
• Analyze and resolve work problems and coach associates in resolving work problems.
• Create and revise Standard Operating Procedures and Standard Forms per ARx process.
• Collaborate and contribute to the development of new products, processes, and equipment.
• Lead the implementation and maintenance of LEAN 6S activities within the Maintenance unit.
• Complete performance assessments of Maintenance associates.
• Conduct disciplinary action and complete proficiency plans for improvement.
• As required, perform direct work, demonstrating ability to perform all the various operations within the department according to documented procedures (QSOP, MSOP, MBR, etc.), protocols, deviations, and training lessons.
• Ensure compliance with all relevant regulations (e.g. ISO, FDA, OSHA, EPA, DEP, etc.) and company procedures.

Additional Responsibilities:

Perform other duties and responsibilities, as assigned.

Job Specifications:

• Engineering degree required.
• Relevant experience with equipment and maintenance required.
• Prior leadership experience (5 years) in a pharmaceutical or similar GMP facility required.
• Conducts activities with professionalism and treats all associates with respect.
• Experience in a cGMP manufacturing environment preferred.
• Possesses a good understanding of manufacturing operations/systems and related processes.
• Requires the ability to work independently, with minimal supervision.
• Possesses good written and verbal communication skills.
• Ability to write SOPs (Standard Operating Procedures).
• Comprehend and follow written procedures (operating procedures, protocols).
• Ability to troubleshoot equipment and processes and identify corrective actions.
• Ability to lead others in execution of tasks.
• Ability to recognize situations requiring PPE and wear proper PPE for extended periods of time. Minimally safety glasses, sleeve covers, and gloves. At times, uses of additional PPE including masks covering mouth and nose for extended periods of time are required.
• Ability to perform basic mathematical functions and apply basic statistical concepts such as mean (average).
• Ability to work with numbers consistently and accurately; able to accurately read, calculate and document numbers repeatedly. Ability to calculate and round to required significant figures.
• Ability to maintain flexibility in schedule and routine in response to fluctuations in inventory and production schedules.
• Work environment involves moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, and irritant chemicals; will be required to use PPE such as masks, gowning, hairnets, gloves, safety glasses/goggles, shields, etc.
• Physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching, or similar activities should be expected.
• Knowledge of MS Word, MS Excel and MS SharePoint.
• Experience with Lean Principles preferred.