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…