What are the responsibilities and job description for the ARx Facilities and Engineerring Manager position at ARx, LLC?
Job Summary:
This position is responsible for the general oversight and supervision of all aspects of facilities management, maintenance, engineering 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.
Essential Functions:
- 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.
- Ensure the maintenance, repair and optimal operation of the facility including HVAC system, plumbing, electrical, USP water, PLC 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.
- Review and approve PMs, WOs, deviations and preventative actions and similar records.
- Organize, coordinate, prioritize, track and document outstanding issues and opportunities.
- Initiate and manage facility/project related change controls.
- Coach and develop maintenance associates. Build the team as necessary.
- Supply period metrics and updates to the senior leadership team to include in period reports.
- Represent the department in change control, biennial review, and other meetings. Assign, execute tasks, and track progress.
- Develop and manage the facilities and engineering budget, ensuring cost control and efficiency.
- Prioritize and allocate resources for maintenance, repairs, and capital projects.
- Provide coordination for and communication within and between all 3 shifts, departments, and levels of the company.
- Maintain workflow and ensure availability and use of proper materials and tools.
- Create and revise Standard Operating Procedures and Standard Forms per ARx process.
- Collaborate and contribute to the development of new products, processes, and equipment.
- Implement sustainability initiatives to improve energy efficiency and reduce operational costs.
- Complete performance assessments, conduct disciplinary action and complete proficiency plans for improvement for direct reports.
- 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:
- College degree required.
- Relevant experience with equipment (HVAC, USP Water Filtration Systems, PLC) and maintenance required.
- Prior leadership experience (5 years) in a GMP manufacturing environment required.
- Conducts activities with professionalism and treats all associates with respect.
- Experience in a Pharmaceutical 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).
