Project Director, Aseptic Operations at AbbVie · LumiJobs

Responsibilities

Aseptic Suite Delivery and Accountability: Lead delivery of aseptic manufacturing suites across multiple modalities, partnering with Project Delivery and global engineering SMEs. Own delivery against approved scope, schedule, budget, and design and construction quality expectations.
Equipment Package and Team Leadership: Lead, coach, and guide package leads responsible for filling machines, isolators, lyophilizers, stopper processors, AVI, autoclaves, and washers. Establish clear accountabilities, align priorities, and resolve issues across equipment packages.
Manufacturing Representation and Decision-Making: Represent Manufacturing throughout the project lifecycle, providing operational requirements and timely decisions. Ensure design choices and equipment acceptance support safe, high-quality, and practical manufacturing operations.
Advanced Manufacturing Technology: Lead implementation of automation, robotics, data analysis, and digital twins within the manufacturing suites. Align technology decisions with operational needs and ensure the manufacturing team is prepared to use the capabilities introduced.
Construction Quality and Technical Acceptance: Partner with Construction and Engineering to ensure suite quality and workmanship meet agreed standards. Provide manufacturing leadership during equipment testing and acceptance at vendor facilities and on site, driving resolution of issues affecting operational readiness.
Commissioning, Qualification, and Start-Up Readiness: Partner with project and commissioning teams to commission and qualify equipment, facilities, and systems. Lead manufacturing procedure development and readiness activities to support the transition from project delivery into operations.
Organization Building and Capability Development: Build the manufacturing organization as start-up and qualification activities accelerate. Define resource needs, recruit and onboard team members, and establish training and development to prepare the team for operational responsibilities.
Transition to Aseptic Operations Leadership: Transition from project delivery into aseptic operations leadership, maintaining continuity of ownership and knowledge. Establish a high-performing manufacturing organization with clear accountability and the highest standards of employee safety and product quality.
Aseptic Practices, Contamination Control, and Quality Culture: Establish operational ownership of aseptic practices and contamination-control expectations. Partner with Quality, Engineering, Validation, and Microbiology/Environmental Monitoring to align the manufacturing operating model with the contamination control strategy
Operational Readiness and Manufacturing Organization: Own Manufacturing Operational Readiness from design through commissioning, qualification, start-up, and routine operations. Build and lead the manufacturing organization, defining staffing, shift strategy, accountabilities across production leadership, frontline supervision, and support functions, SOPs, operating procedures, and manufacturing business processes. Develop capability through structured onboarding, technical training, qualification, and leadership development.
Manufacturing Performance and Supply Reliability: Establish performance expectations for safety, quality, schedule adherence, throughput, yield, equipment reliability, and operating efficiency. Develop production strategies for the intended product mix and multi-product operating model. Partner with Supply Chain, Maintenance, Engineering, Quality, and Technical Operations to resolve constraints and improve line performance while balancing GMP compliance, supply reliability, capacity, cost, and operational flexibility.
Bachelor’s degree in engineering, pharmaceutical sciences, manufacturing, or a related technical discipline, or an equivalent combination of relevant education and experience.

Qualification

ExtensiveStrategic and execution leadershipAseptic manufacturing expertiseCross-functional influenceTechnical judgment and problem-solvingPeople leadershipDigital and technology fluencyCommunication and transition leadership

Required

Experience in roles that supported capital project delivery, C&Q, start-up and forming operational teams is preferred.
Extensive, progressively responsible experience in aseptic manufacturing, engineering, including leadership of complex manufacturing equipment or facility programs.
Hands-on leadership experience across equipment design reviews, vendor and site acceptance testing, commissioning, qualification, and manufacturing start-up.
Experience building and developing teams, establishing manufacturing procedures and training, and preparing an organization for operational readiness.
Experience implementing advanced manufacturing technologies and translating project delivery knowledge into sustainable operational capability.
Strategic and execution leadership: Ability to connect project delivery decisions with long-term manufacturing needs while maintaining accountability for results.
Aseptic manufacturing expertise: Strong understanding of aseptic process equipment, suite integration, and operational safety and quality requirements.
Cross-functional influence: Ability to align Manufacturing, Engineering, Project Delivery, Construction, commissioning teams, and equipment vendors around timely decisions.
Technical judgment and problem-solving: Ability to evaluate complex equipment and facility issues, assess delivery and operational impacts, and drive resolution.
People leadership: Strong coaching, recruitment, resource planning, and capability-development skills.
Digital and technology fluency: Ability to guide implementation of automation, robotics, data analysis, and digital twins in manufacturing.
Communication and transition leadership: Ability to communicate priorities and decisions clearly and lead teams from project execution through start-up into routine operations.

Project Director, Aseptic Operations

Responsibilities

Qualification

Required

Benefits

Company

AbbVie

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