Global Senior PM - Capital Projects & C&Q Leadership

AbbVie Inc.; Missouri; On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Inc. seeks a seasoned project leader to drive capital investment projects across the AbbVie Network.

You will lead cross-functional teams through engineering, design reviews, procurement support, scheduling and commissioning to deliver programs on time. You will coordinate with architectural, CM and vendor teams, and develop C&Q strategies aligned with FDA, GMP, and ICH standards, with travel as needed.

Qualifications

• Bachelor’s degree in engineering, Science, Life Sciences, or related field.
• 10+ Years’ experience in project management / execution, commissioning & qualification in 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 an advantage.
• Ability to work with architectural, CM teams and main trades in a fast-paced project environment.
• Understanding of process and construction safety requirements with experience in HAZOPs and safety metrics.
• Experience leading cross-functional project teams and driving a team to deliver.
• Must have experience in project management or C&Q lead role.
• Knowledge of Automation, CSV, Utility, Facility & Equipment qualification; DCS and CSA experience an advantage.
• Excellent written and verbal communication and risk-based commissioning/qualification knowledge per ISPE C&Q 2019.

Responsibilities

• Provide Leadership for new capital investment projects across the AbbVie Network.
• Direct and lead stakeholders and SMEs through design reviews for facility, Utility and manufacturing equipment.
• Deliver capital plan latest best estimates (LBE) as per established frequency by finance and project accounting.
• Deliver periodic project status reports and gate reviews to stakeholders and track progress.
• Coordinate and lead shutdown related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering Turnover packages.
• Engage with Global Engineering standards for facilities, utilities and equipment.
• Manage equipment suppliers during procurement, design, build and C&Q phases.
• Onboard SMEs to support project needs and drive project lifecycle.
• Lead, motivate and supervise a highly skilled team with technical guidance.
• Support commissioning and qualification strategies in line with FDA, GMP policies.
• Plan and coordinate C&Q activities with risk-based RBV.
• Incorporate deliverables into project scheduling tools and monitor EV weekly.
• Coordinate with engineering, quality, operations, maintenance and external vendors.
• Drive risk assessment consistency and maintain risk-based approach.
• Review and approve documentation, support inspections, and provide SME on qualification.
• Stay current with regulatory changes and industry best practices.
• Collaborate with Global Engineering, Site Operations and Quality for handover and knowledge transfer.

Skills

Project management

Regulatory knowledge

Cross-functional leadership

Communication skills

Risk-based commissioning

Scheduling & resourcing

Team leadership

Vendor management

Education

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

Job description

AbbVie Inc. seeks a seasoned project leader to drive capital investment projects across the AbbVie Network.

You will lead cross-functional teams through engineering, design reviews, procurement support, scheduling and commissioning to deliver programs on time. You will coordinate with architectural, CM and vendor teams, and develop C&Q strategies aligned with FDA, GMP, and ICH standards, with travel as needed.