Calibration and Instrumentation Lead

At Pfizer, we believe that every role contributes to our mission of improving patients' lives.

In this role, you will play a pivotal role in overseeing the maintenance and reliability engineering tasks, which include the redesign, upkeep, and repair of utility systems, buildings, and both production and non-production equipment.

Key Responsibilities

• Act as the Subject Matter Expert (SME) for Calibration, providing technical leadership and guidance on calibration strategies, regulatory requirements, industry best practices, instrumentation lifecycle management, investigations, deviations, and audit readiness.
• Plan, schedule, and execute calibration, qualification, and periodic requalification activities for instruments and equipment.
• Review and approve qualification documents, including URS, FAT, SAT, IQ, OQ, PQ, PRQ, and PV protocols, as well as engineering drawings and layouts.
• Maintain instrument master data and calibration records in EAMS, ensuring accuracy and data integrity.
• Ensure compliance with cGMP, GDP, 21 CFR Part 11, site procedures, and applicable regulatory requirements.
• Lead change controls, investigations, CAPA implementation, and audit observation closures.
• Support internal, customer, and regulatory audits and inspections.
• Coordinate internal and external calibration activities with vendors and cross-functional teams.
• Monitor equipment performance, calibration deviations, and breakdown trends, and implement corrective and preventive actions.
• Lead troubleshooting and reliability improvement initiatives to minimize downtime and optimize equipment performance.
• Ensure timely execution and documentation of maintenance and calibration activities.
• Identify, qualify, and manage calibration service providers.
• Support the installation, commissioning, qualification, and lifecycle management of new equipment and engineering systems.
• Drive continuous improvement initiatives focused on reliability, productivity, energy efficiency, and cost optimization.
• Coordinate engineering projects and stakeholder activities to ensure timely and successful project execution.
• Lead, coach, and develop team members through performance management, training, mentoring, and Individual Development Plans (IDPs).
• Foster a culture of GMP compliance, safety, data integrity, operational excellence, and continuous improvement.
• Provide technical support and guidance during critical maintenance, calibration, and troubleshooting activities.
• Prepare and review engineering performance reports, reliability metrics, MIS dashboards, and budget forecasts.
• Analyze equipment performance data and identify opportunities for improvement.
• Manage departmental budgets and ensure effective utilization of resources.
• Ensure compliance with Environmental, Health & Safety (EHS) requirements and company policies.
• Promote safe work practices through risk assessments, safety walkthroughs, and employee engagement.
• Maintain high standards of housekeeping, workplace safety, quality, and compliance.

Technical Competencies

• Expertise in calibration methodologies, instrumentation, and regulatory compliance requirements.
• Hands-on experience with FAT, SAT, IQ, OQ, PQ, PRQ, and PV activities.
• Strong knowledge of cGMP, GDP, 21 CFR Part 11, cleanroom requirements, and regulatory audit expectations.
• Sound understanding of field instruments, sensors, automation systems, and calibration management software.
• Proficiency in technical documentation, root cause analysis, deviation management, and CAPA implementation.

Leadership Competencies

• Strong problem-solving, analytical, and decision-making skills.
• Effective stakeholder management and cross-functional collaboration.
• Excellent communication, coaching, and team leadership capabilities.

Requirements

• Degree or Diploma in Electronics & Instrumentation Engineering, Electrical & Electronics Engineering, or a related engineering discipline.
• Minimum 10 years of experience in calibration, instrumentation, and engineering maintenance within a regulated manufacturing environment, preferably in the pharmaceutical industry.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.