Senior Project Manager

AbbVie Inc.; Westport; On-site; EUR 110,000 - 140,000; Full time

Job summary

AbbVie Inc. is seeking an experienced Project Manager to lead capital investment projects across the AbbVie network. You will define capital funding, oversee preliminary and detailed design, procurement support, scheduling, contractor management and commissioning.

You will coordinate with architectural firms, CM teams and key trades to maintain schedules, manage risk, and drive on-time project delivery. Travel to support global projects is required.

Qualifications

• Bachelor’s degree in engineering, science, life sciences, or related field.
• 10+ years’ experience in project management/execution, commissioning & qualification in pharma/biotech/regulated industry.
• Strong knowledge of FDA, GMP, ICH Q8/Q9/Q10 and industry standards.
• Experience coordinating with architectural/CM teams and main trades to maintain schedules.
• Ability to lead cross-functional teams and drive project delivery on time/budget.

Responsibilities

• Provide leadership for capital investment projects across AbbVie's network.
• Lead design reviews for facility, utility and equipment.
• Deliver LBE with finance and project accounting.
• Produce weekly/monthly project progress reports and gate reviews.
• Coordinate shutdown activities and final turnover packages.
• Drive C&Q activities with risk-based approach and RBV alignment.
• Mentor and develop SMEs and project teams to achieve objectives.
• Interface with quality, operations, maintenance and vendors to ensure deliverables.

Skills

Project management

Cross-functional leadership

Regulatory knowledge

Vendor management

Planning & scheduling

Education

Bachelor’s degree in engineering, science, life sciences, or related field

Tools

Distributed control systems (DCS)

CSV (Computer System Validation)

CSA

ISPE C&Q guidelines

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