Manager, Facilities and Equipment Services - PTL

Job Description Summary
Manages and coordinates daily Facilities and Equipment service operations including safety testing, repair, maintenance, and user support. Establishes standards and procedures for equipment maintenance, testing, calibration, documentation, and inventory processes. Provides technical leadership and develops applicable training and resources for staff to ensure correct and safe operations of all equipment and devices. Manages the maintenance, construction, repair, and refurbishment operations for one Plasma Testing Laboratory location. Implements policies and procedures that ensure the optimal functioning of buildings, grounds, and associated equipment. Monitors daily building operations to ensure reliability, quality, and adherence to service standards. Works with vendors to maintain up-to-date information about projects, products and Equipment upgrades.
Job Description
PRIMARY DUTIES AND RESPONSIBILITIES

• Manages routine preventative maintenance and repairs for refrigerated and frozen storage units, HVAC, generators, uninterruptible power supply (UPS), environmental monitoring systems, deionized water systems, and other equipment and associated systems as required. Liaises with landlord and/or external vendors for maintenance and repairs. Ensures minimal downtime for the repair of disabled equipment. Coordinates after-hours coverage of all systems to ensure effective emergency response.
• Manages preventive maintenance activities, and their associated vendors/contractors, for fire protection and alarm systems, building remodels and repairs, landscaping, ice/snow removal, cleaning services, etc. Coordinates safety initiatives for the laboratory in conjunction with the Safety Officer and Safety Committee.
• Manages the CMMS to ensure that the system manages scheduled and nonscheduled calibration work orders, trends of calibration data, and data is up to date and accurate.
• Leads cross-functional and regional efforts to establish best practices. Performs operational review and approval of standard operating procedures as needed in accordance with CTS, CFR, CLIA, and AABB standards. Assures proper document control. Partners with quality and operations leaders to ensure regulatory requirements are met, including corrective action, error management, etc..
• Performs routine calibration, verification, and re-verification of ancillary laboratory equipment, warehouse, and refrigeration/frozen storage units in compliance with NIST, cGMP, EUA, AABB, or other regulations, company policies, and procedures.
• Serves as a resource to operations to troubleshoot quality control, equipment, and instrumentation problems. Assures regular review of equipment/assay performance, maintenance, quality control, and quality assurance records.
• Provides subject matter expertise during regulatory audits and inspections, and responds directly to inquiries. Ensures audit readiness for laboratory Facilities and clinical equipment operations.
• Manages the laboratory biohazard waste disposal process and their associated records.
• Manages a team. Provides staff development, performance management, and their associated administrative procedures. Ensures staff competency by participating in required training and continuing education programs.
• Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
• Manages departmental budget to ensure control of expenses.
• Supports the Directors of Operations with strategic planning and goal setting, and budget for operating and capital expenditure budgets for each laboratory. Develops cost analyses for projects, procedures, and facility repairs/improvements.
• Supports and participates in implementation of operational and Organizational Excellence initiatives, e.g., stakeholder meetings, standard work, deviation management, and process improvements. Partners with internal and external stakeholders to support lab initiatives and manages assigned projects, such as business continuity planning, and implementation of clients, assays, equipment, software, and facility changes. Adheres to the CTS project management processes.
• May be responsible for assisting in the facilitation of the laboratory proficiency tests system, if assigned.
• Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
• Assures quality customer service to all customers.
• Maintains good attendance and punctuality per the absence policy.
• Performs all other duties at the discretion of management, as assigned.

REQUIRED QUALIFICATIONS

• Education: Bachelor's degree in Science, Electrical, Mechanical Engineering, or other related field required.
• Experience: 7 years of relevant experience in a high-volume laboratory or pharmaceutical manufacturing environment required To Include: Demonstrated clinical instrumentation expertise and at least 2 years of lead, supervisory, and/or management experience required.
• Demonstrated knowledge of European, federal, state, and local regulations as they relate to technical / clinical operations required.
• Must possess experience with change management, organizational planning, and project implementations.

PREFERRED QUALIFICATIONS

• MT (ASCP) certification.
• PMP Certification.
• Certified Facility Manager (CFM) certification.

SKILLS AND ABILITIES

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
• Must be able to maintain confidentiality.
• Able to organize, prioritize, and execute a variable workload and multiple priorities.
• Ability to work in a team environment and participate as an active member of management.
• Effective oral and written business communication skills.
• Ability to think strategically, synthesize complex business and financial data, and develop innovative solutions.
• Must have proficient computer skills.
• Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate senior-level directors and managers.

PHYSICAL & TRAVEL REQUIREMENTS

• Travel: <10%
• Lab and office work environment: Exposure to biological fluids with potential exposure to infectious organisms. Exposure to extreme cold below 32 °C, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment required such as protective eyewear, garments and gloves.
• 5+ hours per shift: Sitting, standing handling, finger dexterity, pinching.
• Up to 3 hours per shift: Walking Climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, carrying/moving/lifting items up to 35 pounds.

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.
Additional Job Details:
Shift 1
Monday to Friday 8:00 AM to 4:30 PM
Creative Testing Solutions is an equal opportunity employer.
EEO/Minorities/Females/Disabled/Veterans
Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to accommodation@mycts.org to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.
Please see the below information about applicant rights and our commitment to compliance:
EEO is the Law
EEO is the Law Supplement
Pay Transparency
e-Verify
All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.