Engineering & Facilities Manager - Randstad USA

job summary:

This role is responsible for overseeing and supervising the Company's Facilities, Maintenance, and Metrology operations, ensuring compliance with cGMP for pharmaceutical manufacturing as per CFR 211 guidelines.

 
location: Glen Rock, Pennsylvania
job type: Permanent
salary: $120,000 - 130,000 per year
work hours: 9 to 5
education: Bachelors
 
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.

 
qualifications:

• 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.
• Work environment involves moderate risks or discomforts, requiring the use of PPE and adherence to safety precautions.
• Physical exertion such as standing, bending, stretching, and similar activities may be expected.
• Proficiency in MS Word, MS Excel, and MS SharePoint.
• Familiarity with Lean Principles is preferred.
• Onsite 100%

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we