Use Your Power for Purpose
At Pfizer, we believe that every role contributes to our mission of improving patients' lives. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. Your leadership will be instrumental 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. Your dedication and focus will enable Pfizer to reach new milestones and provide aid to patients worldwide.
What You Will Achieve
In this role, you will:
- Responsible for leading calibration, qualification, maintenance, and compliance activities for engineering instruments and systems to ensure equipment reliability, regulatory compliance, operational excellence, and business continuity.
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.
Values & Behaviors
- Demonstrate organizational values of Courage, Equity, Excellence, and Joy.
- Act as a role model for safety, quality, compliance, and data integrity.
Here Is What You Need (Minimum Requirements)
Qualifications & Experience
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.
Bonus Points If You Have (Preferred Requirements)
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Engineering