Senior Project Manager

Description

This is a global senior project manager role for capital investment projects across the company's network, covering the work from concept through to handover.

The company develops medicines and solutions in immunology, oncology and neuroscience, and has an aesthetics portfolio.

You will build integrated schedules and resourcing estimates that keep projects on track.

You will work with architectural, engineering and construction management partners on concept design, detailed design and program planning, so projects meet current regulatory requirements.

You will oversee facility, utility and equipment suppliers, and lead commissioning and qualification (C&Q) programs so systems are designed, installed, tested and run as intended.

You will work with site functional teams on process flow mapping, quality risk assessments, vendor and resourcing management, and C&Q execution.

You will bring in and manage teams of specialist subject matter experts to meet project schedules.

The role requires travel to support projects across the network.

Responsibilities

• Lead new capital investment projects across the network, from funding definition and preliminary engineering through detailed design, procurement, scheduling, contractor management and commissioning.
• Lead, motivate, supervise and guide a highly skilled team with technical direction throughout the project lifecycle.
• Direct stakeholders and subject matter experts through design reviews of facilities, utilities and manufacturing equipment.
• Manage equipment suppliers through procurement, design, build and C&Q.
• Bring in subject matter experts, including package leads and C&Q specialists, as project needs require.
• Deliver the capital plan's latest best estimates on the frequency set by finance and project accounting.
• Prepare periodic status reports and run gate reviews for stakeholders, and track weekly and monthly progress against agreed schedules.
• Enter deliverables into scheduling tools and report earned value (EV) on a weekly basis.
• Coordinate and lead shutdown activities with all stakeholders.
• Lead final walkdowns, punch list close-out and engineering turnover packages.
• Build proficiency in global engineering standards, with a focus on those for facilities, utilities and equipment.
• Develop and implement commissioning and qualification strategies that follow company policy and regulatory guidance such as FDA and GMP.
• Plan and coordinate C&Q activities using a risk-based approach (RBV).
• Keep risk assessments consistent throughout the project lifecycle under a defined risk-based approach.
• Review and approve project documentation, aiming for it to be right first time.
• Support internal or external inspections and advise on qualification activities.
• Keep up with changes in regulations and industry best practice.
• Work with global engineering project engineers, site operations, PDS&T and quality to give technical guidance and drive projects to completion and handover, and transfer processes to site technical and operations SMEs.

Requirements

• Bachelor's degree in engineering, science, life sciences or a related field.
• 10+ years in project management or execution, and commissioning and qualification, in pharmaceutical, biotechnology or a similar regulated industry.
• Strong knowledge of FDA, GMP, ICH Q8, Q9 and Q10 and relevant industry standards.
• Good understanding of risk-based commissioning and qualification under ISPE C&Q (2019).
• Previous experience in project management or as a C&Q lead is required.
• Clear grasp of current legislation, industry expectations and company requirements on process and construction safety, including taking part in HAZOPs and tracking construction safety metrics.
• Experience completing final walkdowns, closing out punch lists and handing over contractor turnover packages with vendors and contractors.
• Experience leading cross-functional teams, with a proven ability to drive and motivate people, which is essential.
• Ability to work with architectural firms, construction management teams and main trades, keep delivery schedules on track and limit delays.
• Ability to schedule tasks, assign resources and deliver on time.
• Knowledge across automation, computer system validation (CSV), and utility, facility and equipment qualification.
• Excellent written and verbal communication skills.
• Self-directed and self-motivated, able to represent the global engineering function.
• Ability to build and maintain working relationships with internal and external stakeholders across the global engineering network.
• Advantage: high technical knowledge of biopharmaceutical drug substance manufacturing and aseptic fill finish.
• Advantage: experience with distributed control systems (DCS) and Computer System Assurance (CSA).

Conditions

Global role with travel across the company's network.

Open only to candidates in the US and Puerto Rico.

The company is an equal opportunity employer that welcomes veterans and people with disabilities.