Laboratory Equipment Management

Element Concord has a current opening for an Laboratory Equipment Manager to join our growing team. The Laboratory Equipment Manageris responsible for leading Element Concords 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.

$90k-$110k DOE

LEADERSHIP AND DEPARTMENT MANAGEMENT

• 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

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 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

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 departments 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

REQUIRED QUALIFICATIONS

• Bachelors 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

#LI-TK1

Element is one of the fastest growing testing inspection and certification businesses in the world. Globally we have more than 9000 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.

At Element we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming the worlds most trusted testing partner.

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for 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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)

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