Senior Project Manager

AbbVie Inc.; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie Inc. in the United States seeks an experienced Project Manager for global capital projects in pharma. You will lead cross-functional teams across design, procurement, and commissioning to deliver on schedule and budget.

The role requires deep knowledge of FDA/GMP, C&Q, and risk-based approaches, with travel to sites within AbbVie network. Strong leadership and communication are essential.

Qualifications

• Bachelor’s degree in engineering, Science, Life Sciences, or related field.
• 10+ years of experience in project management/execution, commissioning & qualification within pharma/biotech or related regulated industry.
• Strong knowledge of FDA, GMP, ICH Q8/Q9/Q10 regulations and industry standards.
• High technical knowledge in Biopharmaceutical Drug Substance Manufacturing and Aseptic Fill Finish is a plus.
• Experience coordinating with Architecture, CM teams and key trades to maintain schedules.

Responsibilities

• Provide leadership for capital investment projects across the AbbVie network, including funding definition, engineering, design, procurement support, scheduling, and commissioning.
• Lead stakeholders and SMEs through design reviews for facility, utility and equipment.
• Deliver capital plan LBE per finance and project accounting schedules.
• Provide weekly/monthly project status reports and gate reviews.
• Coordinate and lead shutdown-related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering turnover packages.
• Adhere to global engineering standards for facilities, utilities, and equipment.
• Manage equipment suppliers during procurement, design, build and C&Q phases.
• Onboard SMEs to support project-specific needs.
• Lead, motivate and supervise a high-skilled project team with technical guidance.
• Support commissioning and qualification strategies aligning with FDA/GMP policies.
• Plan and coordinate C&Q activities using a risk-based RBV approach.
• Incorporate deliverables into scheduling tools and monitor earned value metrics.
• Coordinate with engineering, quality, operations, maintenance and external vendors to ensure on-time, on-budget delivery.
• Drive risk assessment consistency with a risk-based approach throughout the lifecycle.
• Review and approve documentation ensuring accuracy of final deliverables.
• Support inspections and provide SME input on qualification activities.
• Stay updated with regulatory changes and industry best practices.
• Collaborate with Global Engineering, Site Operations, PDS&T and Quality to drive knowledge transfer.

Skills

Project management

Regulatory knowledge

Cross-functional leadership

Communication skills

Risk assessment

Education

Bachelor’s degree in engineering, Science, Life Sciences, or related field

Tools

DCS/CSA knowledge

Job description

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 www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply