# Calibration and Instrumentation Lead

**Company**: Pfizer
**Location**: Vizag, India
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Vizag/Sr-Team-Leader---Calibration_4963426?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/calibration-and-instrumentation-lead-5d6e3d95-ae5/

## Description

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.

For more fresh new jobs, check out [yubhub.co](https://yubhub.co/).

## Skills

### Required
- calibration methodologies
- instrumentation
- regulatory compliance
- cGMP
- GDP
- 21 CFR Part 11
- cleanroom requirements
- field instruments
- sensors
- automation systems
- calibration management software
- technical documentation
- root cause analysis
- deviation management
- CAPA implementation

### Nice to have
- AI tools
- generative technologies
- ChatGPT
- Microsoft Copilot

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/India---Vizag/Sr-Team-Leader---Calibration_4963426?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)