Equipment Management and Environmental Monitoring Manager

Element Materials Technology•Concord, CA

2d•Onsite

About The Position

Element Concord has a current opening for an Equipment Manager/Environmental Monitoring Manager to join our growing team. The Equipment Management/Environmental Monitoring Manager is responsible for leading Element Concord’s Cleanroom Services, Equipment Management programs, and client Environmental Monitoring (EM) services. This role oversees department operations, personnel training and development, technical execution, client communication, and compliance with applicable quality, client, and regulatory requirements. The position ensures services are performed safely, accurately, on time, and in accordance with established procedures and standards, including ISO/IEC 17025, USP, GMP, FDA, and ICH guidelines.

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

Responsibilities

Provide day-to-day leadership, direction, coaching, and oversight for Environmental Monitoring personnel
Manage equipment lifecycle activities in support of equipment calibration, validation, and PM activities
Support personnel training, qualifications, mentoring, workload planning, and development to ensure assigned duties are performed competently and consistently
Promote a culture of safety, quality, accountability, continuous improvement, and compliance with Element policies and procedures
Ensure departmental activities are prioritized and completed in alignment with client commitments, internal timelines, and business needs
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
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 are performed in compliance 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 and support timely investigation, corrective action, and effectiveness activities as applicable
Support cleanroom qualification, requalification, contamination control, and operational readiness activities as required
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
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

Benefits

Element is one of the fastest growing testing, inspection and certification businesses in the world.
Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries.
Together we share an ambitious purpose to ‘Make tomorrow safer than today’.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose.
From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company.
We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work.
The role we have to play in creating a safer world is much bigger than our organization.
We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard to the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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