Company Description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience
- and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. 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. Robust 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 delay

📌 Senior Project Manager (Mary's Harbour)
🏢 AbbVie
📍 Mary's Harbour