Equipment Management and Environmental Monitoring Manager

Element Concord has an opening for an Equipment Manager/Environmental Monitoring Manager to lead Cleanroom Services, Equipment Management programs, and client Environmental Monitoring (EM) services. This role oversees department operations, personnel training, technical execution, client communication, and compliance with quality, regulatory, and client requirements.

Pay range: $90,000–$110,000 DOE.

Responsibilities

• Leadership and Department Management
  • Provide day-to-day leadership, direction, coaching, and oversight for Environmental Monitoring personnel.
  • Manage equipment lifecycle activities in support of calibration, validation, and preventive maintenance.
  • Support personnel training, qualifications, mentoring, workload planning, and development to ensure duties are performed competently and consistently.
  • Promote a culture of safety, quality, accountability, continuous improvement, and compliance with Element policies.
  • Ensure departmental activities are prioritized and completed in alignment with client commitments, internal timelines, and business needs.
• Equipment Management
  • Oversee equipment management activities, including qualification support, calibration, preventive maintenance, repair coordination, and equipment status tracking.
  • Ensure equipment used for laboratory and cleanroom operations remains appropriately maintained, documented, and suitable for use.
  • Coordinate vendor services and internal stakeholders to support timely completion of equipment-related activities.
  • Support equipment-related investigations, change controls, risk assessments, and continuous improvement initiatives.
• Environmental Monitoring and Cleanroom Services
  • Manage Environmental Monitoring services and cleanroom-related activities to ensure sampling, testing, and documentation are performed in accordance with approved procedures and client requirements.
  • Ensure monitoring and laboratory activities comply with applicable quality system, regulatory, and data integrity expectations.
  • Oversee preparation, review, and execution of protocols, procedures, forms, and reports associated with Environmental Monitoring and cleanroom operations.
  • Review Environmental Monitoring data, trends, deviations, and excursions; support timely investigation, corrective action, and effectiveness activities.
  • Support cleanroom qualification, requalification, contamination control, and operational readiness activities.
• Quality, Compliance, and Documentation
  • Ensure department activities comply with the Quality Manual, applicable SOPs, client requirements, and relevant regulatory expectations.
  • Maintain documentation practices consistent with Good Documentation Practices (GDP) and data integrity requirements.
  • Support internal audits, client audits, regulatory inspections, and quality system assessments within the department’s scope.
  • Review and support SOPs, protocols, reports, deviations, CAPAs, and change controls associated with Environmental Monitoring, cleanroom services, and equipment management.
• Client Communication and Business Performance
  • Communicate professionally with clients to discuss project requirements, resolve issues, support customer satisfaction, and maintain strong business relationships.
  • Ensure efficient departmental operations and support achievement of revenue, EBITDA, productivity, and service delivery objectives.
  • Identify and implement process improvements that strengthen compliance, efficiency, turnaround time, and customer experience.

Requirements

• Bachelor’s degree or higher in Microbiology, Engineering, Biology, Life Sciences, or a related scientific discipline.
• Minimum of two years of experience, preferably in a GMP-regulated laboratory or related controlled environment.
• Hands-on knowledge of Environmental Monitoring programs and cleanroom operations.
• Working knowledge of applicable standards and regulatory expectations, including ISO/IEC 17025, USP, GMP, FDA, and ICH guidelines.
• Strong organizational, written communication, verbal communication, problem-solving, and prioritization skills.
• Ability to lead personnel, coordinate cross-functional activities, and manage multiple priorities in a fast-paced laboratory environment.
• Prior supervisory or management experience in a laboratory, cleanroom, pharmaceutical, biotechnology, or contract testing environment.
• Experience with equipment lifecycle management, calibration programs, preventive maintenance systems, investigations, CAPAs, and change control processes.
• Experience supporting client audits, regulatory inspections, or quality system assessments.

Physical and Work Environment Requirements

• Ability to work in laboratory and controlled cleanroom environments as required.
• Ability to wear required personal protective equipment (PPE).
• Ability to stand, walk, and move between laboratory, cleanroom, and office areas as business needs require.
• Other duties may be assigned as needed.