engineering & facilities manager

Randstad • Glen Rock, PA

382d • $120,000 - $130,000

About The Position

The Engineering & Facilities Manager is responsible for overseeing the Facilities, Maintenance, and Metrology operations within the company, ensuring compliance with current Good Manufacturing Practices (cGMP) for pharmaceutical manufacturing as per CFR 211 guidelines. This role involves supervising teams, coordinating maintenance activities, and ensuring adherence to safety and quality standards in a manufacturing environment.

Requirements

• College degree (or equivalent) preferred; relevant experience in equipment and maintenance is required.
• At least 2 years of leadership experience in a manufacturing environment is required.
• Professional demeanor with a focus on respect for associates.
• Experience in a cGMP manufacturing environment is preferred.
• Strong understanding of manufacturing operations, systems, and related processes.
• Ability to work independently with minimal supervision.
• Excellent written and verbal communication skills.
• Ability to write SOPs and comprehend written procedures.
• Skilled in troubleshooting equipment and processes and implementing corrective actions.
• Leadership capabilities to guide teams in task execution.
• Ability to recognize situations requiring Personal Protective Equipment (PPE) and wear it for extended periods.
• Basic mathematical and statistical skills, with the ability to accurately document and calculate numbers.
• Flexible schedule and ability to adjust to inventory and production schedule changes.

Nice To Haves

• Familiarity with Lean Principles is preferred.

Responsibilities

• Supervise Maintenance and Metrology teams to ensure compliance with company procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Safety Policies.
• Coordinate and oversee maintenance activities to ensure alignment with Company procedures, cGMP, DEA, and CFR 211 regulations, including Preventive Maintenance (PMs), Work Orders (WOs), and calibrations.
• Review and approve PMs, WOs, and Calibration records for accuracy and compliance.
• Organize, prioritize, and track outstanding maintenance and metrology issues.
• Supervise and coordinate support and improvement work, including Deviation Investigations, Preventive Actions (PAs), Change Controls, and Biennial Reviews (MSOP/PMSOP).
• Review and approve deviations and PAs not executed by direct team members.
• Initiate and manage facility and project-related Change Controls.
• Analyze and resolve maintenance issues, formulating solutions for team discussion.
• Provide coaching and development for maintenance and metrology associates, building the team as necessary.
• Report performance metrics and updates to the Director of Operations for inclusion in periodic reports.
• Represent the Maintenance department in meetings related to Change Controls, Biennial Reviews, and other activities.
• Facilitate communication and coordination across all shifts, departments, and levels of the organization.
• Ensure the availability and use of necessary materials and tools to maintain workflow.
• Maintain clean, controlled, and properly maintained company facilities in accordance with GMP standards.
• Resolve work-related problems and coach associates on problem-solving techniques.
• Develop and revise Standard Operating Procedures (SOPs) and forms as per company processes.
• Collaborate in the development of new products, processes, and equipment.
• Lead the implementation of LEAN 6S activities within the maintenance department.
• Conduct performance assessments and provide ongoing coaching to operators.
• Handle disciplinary actions and oversee proficiency improvement plans.
• Perform direct tasks as required, demonstrating proficiency in operations according to procedures, protocols, deviations, and training.
• Ensure compliance with relevant regulations (e.g., ISO, FDA, OSHA, EPA, DEP) and company policies.

Benefits

• Health insurance coverage
• Incentive and recognition program
• 401K contribution

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree