Biological Decommissioning/ Recommissioning SME (Finance)

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Job Title: Biological Decommissioning/Recommissioning SME
Location: Remote with some travel to client site in the greater Baltimore, MD
Job Type: Fractional - 16-20 hours/week; estimated for 6 weeks

Job Summary:

The Biological Decommissioning/Recommissioning Subject Matter Expert (SME) is responsible for reviewing and assessing all activities related to the decommissioning and recommissioning of biological manufacturing facilities and equipment. The role requires strong expertise in assessing decommissioned facilities, including critical utilities such as HVAC, water, and environmental systems, to ensure proper shutdown and compliance. The SME will conduct GMP gap analyses, develop and manage remediation strategies, and support supply chain operations including cold chain logistics and materials management.

Key Responsibilities:

Facility & Equipment Assessment:

• Conduct in-depth assessments of decommissioned manufacturing areas and facility systems to determine their condition and compliance status.
• Evaluate whether critical utilities-such as HVAC (air handling, filtration, environmental control) and water systems (WFI, PW, RO)-were decommissioned properly and according to GMP expectations.
• Identify compliance risks and operational impacts related to incomplete or improper shutdowns.

Gap Closure Planning & Remediation:

• Perform GMP gap analyses and generate structured risk-based reports.
• Develop remediation strategies, recommending corrective actions for improperly decommissioned systems.
• Establish remediation timelines
• Coordinate cross-functional execution of gap closure plans with Quality, Engineering, Facilities, and Operations teams.

Decommissioning & Recommissioning Oversight:

• Lead decommissioning/recommissioning activities for equipment, facilities, and supporting systems.
• Review and approve related documentation, including change controls, protocols, and final reports.
• Support facility requalification efforts (IQ/OQ/PQ) and ensure systems are compliant for return to GMP use.

GMP Compliance & Documentation:

• Conduct reviews of decommissioning documentation to verify it meets regulatory and internal standards.
• Ensure all activities are properly documented for regulatory inspection readiness.

Supply Chain & Materials Management:

• Manage readiness of incoming materials for recommissioned operations.
• Ensure material receiving, storage, and inventory systems are GMP and GDP standards.
• Ensure cold chain logistics and temperature-controlled storage systems are validated and compliant.

Qualifications:

• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in GMP-regulated environments, with a focus on facility systems and operational readiness.
• Proven experience in decommissioning/recommissioning critical systems, including HVAC and water systems.
• Strong understanding of GMP facility requirements, including environmental control and utility validation.
• Demonstrated ability to perform GMP gap analyses and implement comprehensive remediation plans.
• Skilled in planning and executing remediation timelines and managing budgets.
• Solid understanding of supply chain operations, warehousing, and cold chain management.
• Excellent documentation, communication, and cross-functional collaboration skills.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.