Engineering Compliance Lead - Maintenance

Use Your Power for Purpose

The Engineering Compliance Lead, Maintenance Level 2, serves as the global process owner and subject matter expert for Pfizer’s Maintenance Good Manufacturing Practice/Good Documentation Practice (GMP/GDP) Level 2 process.

Why This Role Matters

This role leads global process governance across Maintenance, Qualified Utilities, Maintenance, Repair and Operations (MRO), and Pest Control, accountable for the design, compliance, performance, health, training and continuous improvement across PGS’ sites and PharmSci network.

The position provides strategic leadership in process standardization, compliance oversight, continuous improvement, and digital enablement, while partnering across the enterprise to reduce risk and strengthen operational performance. The role acts as the L2 Process Centric (PCT) Leader and is responsible for driving global process standardization, regulatory alignment, and sustainable process excellence.

Key responsibilities include:

Own and govern the global Maintenance Level 2 process (across Maintenance, Qualified Utilities, Maintenance, Repair and Operations (MRO), and Pest Control), including process design, deployment, monitoring, and continuous improvement. This includes 4 x Global SOP’s (GSOP’s), 11 Global Work Instructions (GWI’s)​, 6 Global Forms and Local Work Instructions across Pfizer Global Supply (PGS) and Pharmaceutical Science (PharmSci)

Lead global Maintenance Level 2 process in areas of Maintenance, Qualified Utilities, MRO, and Pest Control. Collaborate with specific workstream SME’s for input in L2 processes.

Lead development and maintenance of 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 (LPO’s) and peer GPO’s 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 drive effective process decisions through the use of data, metrics, and regulatory intelligence to 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 in order to build network capability.

As a Change Agent, lead change effectively across a global network while promoting a strong culture of compliance, accountability, and operational excellence.

CORE COMPETENCIES

The GPO demonstrates the following core competencies required for successful performance of the role:

Regulatory & GMP/GDP Expertise: Demonstrates strong working knowledge of global GMP/GDP regulations and regulatory authority expectations. Interprets regulatory requirements and translates them into practical, compliant engineering and operational controls.

Quality Systems & Process Compliance: Applies deep understanding of Quality Management Systems (QMS), including deviation management, CAPA, change control, and risk management. Ensures engineering processes and procedures are compliant, standardized, and effectively implemented.

Risk-Based Decision Making: Identifies, assesses, and manages compliance risks using structured, risk-based methodologies. Proactively mitigates risk and supports sound, defensible decisions aligned with regulatory and business expectations.

Audit & Inspection Readiness: Supports internal and external audits and regulatory inspections. Confidently explains engineering systems, processes, and compliance rationales, and contributes to effective and sustainable responses to observations.

Technical & Engineering Authority: Applies strong engineering fundamentals to provide credible technical oversight of asset design, qualification, operation, and lifecycle management. Ensures systems are fit for intended use and compliant throughout their lifecycle.

Change, Improvement & Metrics: Evaluates compliance impacts of engineering and process changes. Applies continuous improvement principles to strengthen compliance maturity while enabling innovation and operational efficiency. Implementation and sustainability of the IMEX PCT for this L-2 with associated elements and metrics.

Data Integrity & Digital Enablement: Champions ALCOA+ principles and digital tools that improve compliance, traceability, and data reliability around asset/maintenance management.

Stakeholder Engagement & Influence: Effectively collaborates with Engineering, Quality, Operations, Digital and Leadership stakeholders. Influences decisions through clear communication, technical credibility, and risk-based recommendations.

Accountability & Judgment: Exercises sound professional judgement and takes ownership for compliance decisions and outcomes. Escalates risks appropriately and acts decisively to protect patient safety, product quality, and regulatory compliance.

Compliance Culture & Leadership: Leads by example in promoting a strong compliance and quality culture. Coaches others on compliant behaviors and reinforces right-first-time execution of engineering and quality practices.

Here Is What You Need (Minimum 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 1+ years of experience.

Relevant experience in pharmaceutical or comparable manufacturing environments

• •Demonstrated experience managing engineering, maintenance, and utilities processes in regulated settings. Foundational knowledge in areas 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, resourceful, and able to lead through complexity

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel of up to 20% may be required, sometimes on short notice. Travel may include North and South America, Europe, Africa/Middle East, and Asia/India. Work hours may vary based on project needs and global time zones.

Other Job Details :

Work Location Assignment: Hybrid

Relocation Assistance: NO

Last date to apply: 11/3/2026

The annual base salary for this position ranges from $124,400.00 to $207,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, F