GMP Metrology Specialist

Responsibilities

• Support the facility and equipment metrology program, including owning the asset management of the Bridgewater, NJ IDMO site
• Provides daily support activities such as documentation, procedure adherence, equipment scheduling, and calibration metrics reporting
• Assure department compliance with applicable internal and external regulatory requirements and procedures. Support internal and external auditing activities
• Supporting the development of calibration protocols, methods, and techniques based on the science of measurement, assuring accuracy and precision
• Ensure that laboratory equipment maintenance and calibration programs are maintained, and production operational requirements are met
• Support the Metrology department calibration metrics (KPIs)
• Provide oversight of calibration suppliers: approval, consolidation, quality, and purchasing
• Coordinate scheduling of vendor maintenance/calibration for GMP equipment
• Support the calibration program schedule and preventative maintenance; ensure on-time completion and review of work orders for accuracy and GMP compliance
• Provide technical support to operations and support personnel, maintaining equipment operations
• Assist in the development of a monthly schedule for GMP clean room maintenance activities
• Manage work requests/orders, including processing, generation, tracking, and follow-up; ensure work order completion, review, approval, and close-out
• Maintain all equipment data within a CMMS
• Ensure all assets are documented, maintenance plans are developed, assets are scheduled, and work orders are complete
• Supporting the development of calibration and equipment maintenance procedures. Author/Review/Approve documents for departmental standard operating procedures (SOPs) and programs
• Supporting the program leadership and team collaboration by completing all assigned projects on time and on budget, and successfully achieving expectations in compliance with our safety policies and company regulations
• Participate in developing corporate-wide systems, procedures, and tools that facilitate efficient processes throughout the organization
• Ensure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facility
• Make critical decisions on equipment/facility issues and emergencies, effectively communicate with management, and escalate issues
• Create a GMP culture mindset within the metrology/engineering team supporting the cell therapy manufacturing organization

Requirements

• Associate’s or technical degree in an engineering-related field, or equivalent relevant work experience, required
• Minimum of 7 years of experience in a regulated industry, including at least 3 years of direct equipment or metrology program management experience
• Experience in cell and gene therapy and/or pharmaceutical manufacturing is strongly preferred
• Working knowledge of applicable governmental and regulatory requirements related to facilities and equipment, including FDA, EMA, and other relevant regulatory standards
• Ability to work independently and collaboratively in a team environment, with proven ability to prioritize and manage multiple tasks while balancing competing priorities
• Demonstrated ability to adapt to shifting priorities and meet critical deadlines in a fast-paced, dynamic, and growing environment
• Ability to read and interpret engineering drawings, schematics, and isometrics
• Excellent verbal and written communication skills
• Strong organizational skills with the ability to multitask effectively and maintain attention to detail
• Demonstrated critical thinking and independent decision-making capabilities.
• Ability to handle confidential information with appropriate discretion
• Strong interpersonal and teamwork skills, with the ability to influence and build effective working relationships across all levels of the organization
• Willingness and flexibility to take on responsibilities outside the normal scope of work as needed.
• Desire to contribute to a rapidly evolving organization with compelling technology and mission
• High level of self-awareness, integrity, authenticity, and a demonstrated growth mindset
• Proficiency in using computerized maintenance management systems (CMMS)