Calibration & Validation Manager

Pharmaceutical Calibration/Validation Manager Job

Job Description:

The Calibration & Validation Engineer Manager is responsible for leading, managing, and continuously improving the organization’s calibration and metrology activities ensuring full compliance with international standards (GMP, FDA, ISO/IEC 17025, and ISO 9001), regulatory requirements, and customer specifications. The position combines strong technical expertise, system development management and leadership role.

Key responsibilities:

· Design & implement the Calibration & Validation department strategy, roadmap, procedure & accreditation readiness, ensuring compliance with international standards and ongoing business needs.

· Establish and maintain calibration policies, SOPs, workflow, work instructions and quality manuals.

· Review & approve calibration methods, validation protocols, results, certificates, and technical reports.

· Ensure data integrity, traceability, and documentation compliance for all calibration and validation activities.

· Specify, select, and procure calibration reference standards and calibration instruments.

· Establish and manage equipment calibration, qualification, verification and re-calibration plans.

· Optimize turnaround times and workflow efficiency for process improvement & Operational Excellence.

· Prepare, control and manage the calibration department budget.

· Sourcing and selecting calibration engineers and technicians according to department needs plan.

· Coach and mentor team members technically and professionally.

· Define competency matrices, training programs, and authorization levels.

· Build and sustain a culture of quality, accuracy, safety, and continuous improvement.

· Drive continuous improvement initiatives and technical innovation.

Job Specifications:

· Bachelor’s degree in engineering (Electrical, Mechanical, Instrumentation, Mechatronics, or related field).

· 10–15 years of progressive experience in calibration, metrology and Validation.

· 3–5 years’ experience in a managerial position or leadership role.

· Strong knowledge of: ISO/IEC 17025, ISO 9001, GMP, FDA

· Previous experience in pharmaceutical, biotech, or regulated manufacturing environments is highly preferred.

· Strategic thinker, strong managerial capability with experience in building systems, teams, and processes

· Excellent decision-making and problem-solving skills

· Strong communication and technical writing and documentation skills

· High sense of ownership, accountability, and attention to details

Work Location: In person