Demo

Facilities and Engineering Manager

Synerfac Technical Staffing
Rock Glen, PA Full Time
POSTED ON 1/14/2025
AVAILABLE BEFORE 3/12/2025
  • 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 (, FDA, OSHA, EPA, DEP, etc.) and company procedures.- College degree (or equivalent) preferred; relevant experience with equipment and maintenance required. - Prior leadership experience (2 years) in a manufacturing environment 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, , working around moving parts, machines, and irritant chemicals; will be required to use personal protective equipment 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.
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