Responsible for the overall coordination of Project Engineering, Equipment, Instrumentation, Control Systems, Maintenance, Systems Engineering, and Calibration for biopharmaceutical facilities used for CTM manufacturing and process development.
• BS/BA in Engineering or equivalent discipline, MS/PhD a plus, with 15 years of relevant industry experience including 10 years management and/or project management experience.
• Proven experience in the leadership of an organization in a GMP setting required.
• Specific leadership experience required in more than one of the following roles/functions: complex matrix teams, capital project teams, design engineering, construction management, system/area start-up, and validation of biopharmaceutical equipment or facilities in the U.S. and international locations.
• Thorough knowledge of FDA and foreign equivalent standards as they apply for biopharm processes, facilities, and validation.
• Experience with design of pharmaceutical pilot plants for flexibility and compliance with cGMP's and direct interaction with external regulatory agencies during inspections.
• Technical understanding and experience with biopharmaceutical production including mammalian and microbial expression, cleaning systems, and contamination risks in Bioprocess equipment and manufacturing.
• Strong leadership, organizational, and interpersonal skills; strong verbal and written communication skills, strong skills in managing individual and team performance.
• Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, quality, and operational disciplines.
• Able to lead critical evaluations, generate options, and make recommendations for implementation.
Preferred qualifications:
• Experienced in LeanSigma tools including root cause analysis, FMEA, and data-driven decision making and project prioritization. Preferred
• Experience in directing contractors and consultants and negotiating their terms and fees.
• Experience in auditing 3rd party contractors for facilities design compliance.
Details:
Responsible for the overall coordination of Project Engineering, Equipment, Instrumentation, Control Systems, Maintenance, Systems Engineering, and Calibration for biopharmaceutical facilities used for CTM manufacturing and process development.
• Provides leadership in multiple technical areas to area customers, including close partnership with GMP Operations senior leadership team and BPD Directors to ensure alignment in strategy and execution of key activities.
• Provides framework for the organization of the Engineering department, key performance indicators, and overall project prioritization in close coordination with the Validation group.
• Has full accountability for equipment/facility reliability and compliance in support of operational deliverables and for the project management of major capital projects.
• Serves as a liaison and is local owner with accountability for relationship between BPDS and WREF to secure funding of BPDS capital projects to enhance quality, capability and capacity of biopharm facilities on the Upper Merion campus
• Serves as a liaison and is local owner with accountability for relationship between BPDS and WREF to ensure maintenance and calibration activities are planned and performed as required to support business needs.
• Ensures the appropriate, risk mitigated introduction of novel technologies for manufacturing and utility systems.
• Participates in Corporate Facilities Master Planning initiatives as BPDS representative.
• Subject matter expert on equipment issues throughout GSK, serving on due diligence teams, auditing 3rd party contractors for facilities design compliance, and representing division on broader R&D harmonization teams.
• Takes a leadership role in operations activities that interact with other Pharmaceutical, Biotechnology and high technology companies.
• Has a significant managerial role in cross-department multidisciplinary teams and may manage multiple operational efforts.
• Advises the functional area Vice President on matters of operational for facilities importance.
• Has overall responsibility for the functional area’s emergency response planning and activation, and business continuity documentation.
• Negotiates, recommends and approves major agreements with vendors and contractors within area of responsibility.
• Role may require on site presence beyond normal working hours as required to resolve engineering systems or emergency response issues
• Responsible for leading local, and when appropriate, transnational technical and engineering support for 250,000 square feet of Biopharmaceutical Development and Clinical Trial Material (CTM) Production Facilities and Laboratories valued in excess of $300 million, including:
o 20+ FTE
o $5.0 million annual site operating budget
o $5 to 7 million annual capital budget
• Primary BPDS liaison to:
o WREF Operations and Capital Engineering
o Capital Procurement
o Facilities Master Planning Prioritization
o Architectural and Engineering Consultants
• Team performs as Primary liaison to:
o Equipment Vendors
o Process Control Configuration Contractors
o Equipment Maintenance Contractors
o Trade Contractors
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