Director, Aseptic DP Process Engineering

Key Responsibilities

• Development and delivery of all process engineering specifications (user requirements, data sheets, technical specifications)
• Assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the process systems
• Technical issue resolution on the system during C&Q testing and the readiness of the system to start C&Q activities
• Helping to identify and expedite key activities across multiple business functions (Manufacturing, Facilities, MSAT, Quality, Procurement, E&PS, and EHS)
• Ensure alignment across evolving business needs and require strong partner management and leadership skills to collaborate across these multiple business partners
• Maintaining a solid understanding of industry trends and benchmarking against internal/external practices
• Actively participate in inclusion initiatives to build a well-rounded, high performing engineering team
• Cultivate a culture of technical excellence, collaboration, and innovation to enable multi-functional learning and standard methodology sharing
• Develop and mentor engineering team members to ensure a strong talent pipeline
• Apply data-driven insights and market intelligence to advise future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance
• Ensure compliance with policies, procedures, government regulations, and customer specifications
• Collaborate with an engineering firm to advance the facility design

Qualifications

Education: Minimum of a Bachelor's Degree in engineering required (Mechanical or Chemical Engineering preferred), MS or MBA preferred.

Experience and Skills

Required:

• A minimum 15 plus years in drug product experience in a biotherapeutics cGMP environment (preferably in process engineering or capital project execution)
• A minimum 5 plus years of people leadership experience
• Shown success in building and developing high performing team
• Track record of developing and maintaining strong partnerships at all levels within the organization, including key stakeholders
• Ability to lead and motivate multicultural teams and remote customers
• Excellent problem-solving skills when handling potential conflicts
• Understanding sophisticated technical/regulatory issues impacting facility/equipment design
• Solid understanding of cGMP’s for aseptic manufacturing of multiple regulatory bodies (EU, FDA), including fluency in the understanding of new EU Annex 1 guidelines and its impact on facility/equipment design
• EHS requirements, with particular focus on EHS by design and construction safety
• Start-up processes and Commissioning & Qualification Principles for Engineering Design for drug products in the Biotherapeutic industry
• Construction & Procurement process
• Project Controls processes
• Project scheduling
• Strong technical process engineering knowledge and experience and has a great passion for solving highly complex technical problems
• Strong problem solving, communication, and decision-making skills to drive impact in a fast-paced evolving business landscape
• Ability to drive process engineering innovation for equipment and facilities ensuring technical knowledge is maintained and expanded throughout the team

Preferred:

• Consistent track record on leading capital projects in the range of 250 – 500 MM$ (preferred)
• Strong process engineering expertise in conceptual design through C&Q (commissioning & qualification) to ensure efficient operational readiness within a biotherapeutic drug product environment
• Leadership experience in a greenfield project(s)

Other: This position will be located in Wilson, North Carolina, and will require full time on-site support. However, the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson, NC.