Sr. Manager, Engineering and Design - Production Facility

About This Role

The Sr. Manager, Engineering & Design will lead a team responsible for designing and supporting the construction and startup of a greenfield pharmaceutical manufacturing site, ensuring alignment with J&J business objectives and regulatory requirements. This role provides technical direction and coordination for process systems on complex capital projects. The position requires initial travel to co-locate with the AE Design Firm, then relocation to Wilson, NC.

Responsibilities

• Prepare/Review Requests for Proposal (RFP) for Architect/Engineer (A/E) services and lead A/E interviews/selection and on-boarding process
• Provide support to develop our standard JNJ contract with AE Firms for engineering and design work
• Lead the overall engineering process including process and infrastructure design working closely with operating company engineering team and J&J SMEs
• Work with the E&D Director, Project Dir./Project Mgr. to drive the performance (cost, schedule, quality) of A/E firm and define correction action plans if necessary
• Assure the appropriate J&J standards, guidelines, and regulatory requirements (cGXP, EHS, …) are incorporated
• Coordinate/lead key design reviews with SMEs including other corporate or affiliate resources such as EHSS, Risk Management, WW Security, etc.
• Coordinate/ lead the Design to Value and Constructability Reviews
• Assure that the J&J Standard Design Platforms are deployed on all projects. Setup project specific training for SMEs.
• Assure projects meet the J&J Sustainability policy and drive the certification process.
• Review AE progress and identify action plans when required to get back on track.

Requirements

• 8+ years of experience in engineering, operations, and/or asset management activities
• Experience delivering large complex capital projects / programs on schedule and budget
• Strong technical background with pharmaceutical manufacturing processes, preferably in aseptic fill, finish and packaging environments
• Ability to develop appropriate metrics for engineering performance and set up plans for continuous improvement
• Demonstrated history of collaboration across other functional areas to establish effective working relationships
• Strong business acumen and relationship building skills
• Proven experience to effectively partner and deliver results in a matrixed environment

Qualifications

• Bachelor’s or higher degree, preferably in Engineering; Master’s degree in Engineering, Business, or related field is preferred
• At least 8 years of related experience in engineering, operations and/or asset management activities

Nice to Have

• Engineering management experience
• Experience working in a lead role at an AE Design Firm or directly leading an AE Firm on a large project
• Experience with Biosafety Level 2 and 2+ design
• Proficiency in project/design management, including acquiring agreement on project definition and priorities, and ensuring that resources, capabilities and processes are in place to deliver the design efficiently and effectively
• Experience leading complex workstreams, specifically across geographically dispersed or global teams

Skills

* Required skills