Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

This role will be responsible for supporting Quality Assurance oversight of Facilities Management activities related to internal GMP operations at both our Quality Control Laboratories located in Woburn, MA and Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA. This role will work closely with the Facilities Management teams at both locations to ensure planned maintenance, unplanned (corrective) maintenance, and calibration activities meet CGMP requirements for the documentation, trending, and escalation of issues. Efforts are focused on ensuring equipment, facilities, and utilities are maintained in a qualified/validated state for Manufacturing and Testing purposes. Core activities include review and approval or maintenance plans, review and approval of unplanned (corrective) maintenance work records, and the development or improvement of maintenance work management processes. This role primarily partners with the Facilities & Engineering teams and closely with Validation, Manufacturing, and Quality Systems.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Provide Quality Assurance oversight for Facilities Management to create, deploy and manage processes that ensure the facilities, utilities, and equipment are maintained in a qualified/validated state, compliant with applicable health authority requirements and expectations. This is demonstrated through:
  • SOPs/Record Management: Approve maintenance procedures, work instructions, work records, and calibration plans directly related to management of facilities, utilities, and equipment
  • Deviation/CAPA Management: Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
  • Validation/Maintenance: Ensure appropriate maintenance and a state of qualification is maintained for equipment, utilities, and facilities in area of responsibility during maintenance work
  • Training: Ensure all personnel working with Facility Management processes, including contractors, consultants and temporary employees have the proper qualifications, skill sets, education, and training to perform their job in accordance with applicable procedures and regulations
• Review and approve maintenance records such as planned and unplanned (corrective) work requests. Ensure they are adequately assessed for impact and trends are escalated as appropriate
• Perform periodic BMRAM audit trail reviews
• Write, review and/or approve deviations (investigations), CAPA, and change controls associated with Facilities Management
• Ensure the appropriate capabilities; procedures and quality mindset are in place to ensure GMP with a focus on data integrity / analysis and management
• Support and maintain Key Quality Performance Indicators for Facility management. Ensure trends are addressed as appropriate
• Participate in inspections and audits for various roles as assigned

Requirements:

• A B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry
• Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles
• Direct experience with facility, equipment, utility, and cleaning validation is required. Experience with cell culture and single use systems is also preferred
• Demonstrated experience working with maintenance management systems (e.g., Blue Mountain)
• Direct experience with analytical instrument qualifications, computer system validation/computer software assurance, and data integrity programs
• Knowledge of relevant FDA and EMA regulations
• Willingness to work in a dynamic and changing corporate environment. Flexible in the face of shifting needs and/or priorities
• Excellent oral and written communication skills with strong technical writing experience is required
• Excellent organizational skills and attention to detail
• Demonstrated analytical approach to problem solving and decision making
• Demonstrated ability to manage multiple priorities for complex projects
• Experience with continuous improvement efforts
• Travel may be required up to 10%. Most travel will be to other Boston-area locations for larger team meetings

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment
• Certain tasks may require the use of a respirator; medical clearance will be required in advance
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment
• Working in temperature-controlled environments (cold rooms)

#LI-CS1 #LI-Onsite