Senior Project Manager

Job Description

The successful candidate will work with cross-functional teams to develop integrated schedules and resourcing estimates to support project delivery.

The role will involve working with 3rd parties such as architectural, engineering and construction management teams to support concept design, detailed design and program planning to ensure projects are delivered in line with current regulatory requirements and expectations.

This role will also be responsible for managing equipment, facility and Utility (FUE) suppliers as needed as well as driving the commissioning and qualification programs thus ensuring all systems are designed, installed, tested, and operate in line with the design intent. This role will also engage with site core functional teams on process flow mapping, quality risk assessments, vendor and resourcing management, and C&Q execution. They will support the onboarding and management of teams of highly skilled subject matter experts to drive the projects in line with project schedules. This is a global role that will require travel to support projects across the AbbVie Network.  

Responsibilities:

• Provide Leadership for new capital investment projects across the AbbVie Network
  • To include but not limited to: Capital funding definition, preliminary engineering, detailed design, procurement support, schedule development / timeline management, contractor management and commissioning.
• Direct and lead stakeholders and SMEs through design reviews for facility, Utility and manufacturing equipment.
• Deliver capital plan latest best estimates (LBE) as per the established frequency by finance and project accounting.
• Deliver periodic project status reports and gate reviews to project stakeholders and track weekly and monthly project progress in line with agreed schedules. 
• Coordinate and lead shut down related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering Turnover packages.
• Become proficient with global engineering standards with particular focus on engineering standards specific to facilities, Utilities and Equipment.
• Manage equipment suppliers as needed during the procurement, design, build and C&Q phases.
• Onboard subject matter experts (Package Leads + C&Q) to support project specific needs.  
• Lead, motivate, supervise and drive a highly skilled team, providing technical guidance and leadership throughout the project lifecycle.
• Support the development and implementation of commissioning and qualification strategies, ensuring adherence to company policies and regulatory guidelines (e.g., FDA, GMP).
• Planning and coordination of C&Q activities in line with a risk-based approach (RBV).
• Articulate and incorporate deliverables into project scheduling tools and management. Manage metrics on a weekly basis to ensure earned value (EV) is monitored. 
• Coordinate with engineering, quality, operations, maintenance, and external vendors to ensure project deliverables are met on time and within budget.
• Drive risk assessment consistency ensuring a well-defined risk-based approach is developed and maintained throughout the project lifecycle.
• Review and approve documentation as necessary ensuring project documentation is always right first time.
• Support internal or external inspections as required and provide subject matter expertise on qualification activities.
• Stay current with changes in regulatory requirements and industry best practices.
• Work closely with Global Engineering Project Engineers, Site Operations, PDS&T and Quality to provide technical guidance and continuous improvement support to drive successful completion and handover of GE projects. Support Knowledge transfer of processes to site Technical / Operation SME

Qualifications

• Bachelor’s degree in engineering, Science, Life Sciences, or related field.
• 10+ Years’ experience in project management / execution, commissioning & qualification within the pharmaceutical, biotechnology, or related regulated industry.
• Strong knowledge of relevant regulations (FDA, GMP, ICH Q8/Q9/Q10) and industry standards.
• High technical knowledge in Biopharmaceutical Drug Substance Manufacturing and Aseptic Fill finish a distinct advantage.
• Demonstrated ability to work and communicate effectively with Architectural firms, CM teams and main trades in a fast-paced project environment.  Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Clear understanding of current legislative, industry and corporate expectations of process and construction safety requirements, with experience in participating in HAZOPs, and in tracking of construction safety metrics.
• Experience of completing final walkdowns, close out of punch lists and handover of contractor turnover packages with vendors and contractors.
• Experience leading cross-functional project teams and proven ability to drive and motivate a team is essential.
• Must have previous experience in project management or C&Q lead role.
• Knowledge of a wide range of project disciplines including Automation, CSV (Computer System Validation), Utility, Facility & Equipment qualification. Experience with distributed control systems (DCS) and Computer System Assurance (CSA) is an advantage.
• Excellent written and verbal communication skills.
• Good understanding of risk-based commissioning and qualification in line with ISPE C&Q (2019).
• Self-directed, self-motivated with an ability to represent the Global Engineering function in a high-paced project environment.
• Ability to interact and communicate within the AbbVie Global Engineering network and maintain strong working relationships with internal and external stakeholders and collaborators.
• Maintain project delivery schedules and mitigate against potential delays. Proven ability to schedule tasks, assign resourcing and deliver on time.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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