Engineering Compliance Lead - Maintenance

Pfizer • New York City, NY

2d • Hybrid

About The Position

The Engineering Compliance Lead, Maintenance Level 2, serves as Pfizer’s global process owner and subject matter expert for the Maintenance Good Manufacturing Practice/Good Documentation Practice (GMP/GDP) Level 2 process. The role leads global process governance across Maintenance, Qualified Utilities, Maintenance, Repair and Operations (MRO), and Pest Control, with accountability for process design, compliance, performance, health, training, and continuous improvement across Pfizer Global Supply (PGS) sites and the Pharmaceutical Science (PharmSci) network.

As the Level 2 Process Centric (PCT) Leader, this role drives global process standardization, regulatory alignment, and sustainable process excellence. It provides strategic leadership in compliance oversight, continuous improvement, and digital enablement, working across the enterprise to reduce risk and strengthen operational performance. The role governs four Global SOPs, eleven Global Work Instructions, six Global Forms, and local work instructions across PGS and PharmSci.

The position partners with Engineering, Quality, Digital, site stakeholders, workstream subject matter experts, Local Process Owners, and peer Global Process Owners to support compliant global implementation. It supports inspection readiness, audits, and inspections; defines requirements for digital tools and data management; and serves as a technical authority for process standards, local work instructions, and enterprise-wide engineering practices. Travel of up to 20% may be required, sometimes on short notice, across regions including the Americas, Europe, Africa/Middle East, and Asia/India. Work hours may vary based on project needs and global time zones. The work location assignment is hybrid.

Requirements

• Bachelor’s degree with at least 6 years of experience, or a master’s degree with more than 5 years of experience, or a Ph.D. with at least 1 year of experience.
• Relevant experience in pharmaceutical or comparable manufacturing environments.
• Demonstrated experience managing engineering, maintenance, and utilities processes in regulated settings.
• Foundational knowledge of Maintenance, Qualified Utilities, MRO, and Pest Control.
• Strong knowledge of pharmaceutical maintenance programs and manufacturing operations.
• Strong knowledge and use of EAMS CMMS.
• Experience with budgeting, purchase order management, and cross-functional program delivery.
• Strong leadership, communication, stakeholder engagement, and change management skills.
• Ability to influence across global sites, technical teams, and business partners.
• Understanding of compliance, market, and operational excellence trends.
• Innovative and resourceful, with the ability to lead through complexity.
• Working knowledge of global GMP/GDP regulations and regulatory authority expectations.
• Understanding of Quality Management Systems, including deviation management, CAPA, change control, and risk management.
• Ability to assess and manage compliance risks using structured, risk-based methodologies.
• Engineering fundamentals sufficient to oversee asset design, qualification, operation, and lifecycle management.
• Knowledge of ALCOA+ principles and digital tools supporting compliance, traceability, and reliable asset and maintenance data.
• Sound professional judgment, ownership of compliance decisions and outcomes, and appropriate risk escalation.

Responsibilities

• Own and govern the global Maintenance Level 2 process across Maintenance, Qualified Utilities, MRO, and Pest Control, including process design, deployment, monitoring, and continuous improvement.
• Lead the global Maintenance Level 2 process and collaborate with workstream subject matter experts for input into Level 2 processes.
• Develop and maintain global standards, standard operating procedures, work instructions, forms, and training materials.
• Provide global leadership for deployment, performance monitoring, issue escalation, training strategy, and process health through the Process Centric Team.
• Influence Local Process Owners and peer Global Process Owners to achieve consistent, compliant global implementation.
• Partner with Engineering, Quality, Digital, and site stakeholders to standardize practices, strengthen compliance, and deliver business value.
• Support inspection readiness and use data, metrics, and regulatory intelligence to inform process decisions and identify risks.
• Support audits and inspections by providing technical expertise, process rationale, and input to sustainable responses.
• Define requirements for digital tools and data management practices that support compliant execution, documentation, and data integrity.
• Serve as technical authority for process-related standards, local work instructions, and enterprise-wide engineering practices to build network capability.
• Lead change across a global network while promoting compliance, accountability, and operational excellence.
• Implement and sustain the IMEX PCT for this Level 2 process, including associated elements and metrics.
• Apply risk-based decision-making, quality systems, continuous improvement, and data integrity principles to engineering and maintenance processes.
• Coach others on compliant behaviors and reinforce right-first-time execution of engineering and quality practices.
• Travel up to 20% as required, sometimes on short notice, and adapt work hours to project needs and global time zones.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a bonus target of 17.5% of base salary.
• Eligibility to participate in Pfizer’s share-based long-term incentive program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior