What are the responsibilities and job description for the Facilities and Engineering Manager position at ClinLab Staffing?
Facilities and Engineering Manager-Glen Rock, PA
Essential Functions :
- Ensures that all Maintenance and Metrology Associates perform their duties per procedure, per Good Manufacturing Practices, per Good Documentation Practices, and per Safety Policy.
- Coordinate and supervise maintenance and metrology associates to ensure core work is completed per procedures, cGMP, DEA and CFR.211 requirements. Core work includes : PMs, Work Orders and Calibrations.
- Review and approve PMs, WOs and Calibration records.
- Organize, coordinate, prioritize and track outstanding issues and opportunities.
- Coordinate and supervise maintenance and metrology associates to ensure support / improvement work is completed per procedures, cGMP, DEA and CFR.211 requirements. Support / improvement work includes : 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.
- Parato the maintenance and facility issues and formulate potential solutions for discussion with team and manager.
- Coach and develop maintenance and metrology 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 the facilities are clean, controlled, and maintained appropriately per 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 per 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.
Job Specifications :
