Facilities and Engineering Manager
Synerfac Technical Staffing Glen Rock
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.
- 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.
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Formulate and execute strategic business plans
• Cultivate a network or potential clients and identify, assess, and prioritize partnerships
• Develop and implement roadmap for future technologies, strategic initiatives, and sales growth
• Secure...