Job Purpose

To support engineering operations within the pharmaceutical manufacturing environment through effective management of engineering documentation, equipment qualification activities, and calibration systems to ensure compliance with GMP requirements, regulatory standards, and company procedures.

Key Responsibilities

Engineering Documentation Management

• Control, maintain, and update engineering documentation including SOPs, protocols, reports, drawings, manuals, and technical records.
• Ensure all engineering documents comply with GMP, data integrity, and document control requirements.
• Coordinate periodic review and revision of engineering documents.
• Maintain accurate documentation archives for audits and inspections.
• Support implementation and continuous improvement of engineering documentation systems.

Qualification Activities

• Prepare and review qualification protocols and reports.
• Coordinate qualification activities for equipment, utilities, and facilities.
• Ensure qualification activities are executed according to approved validation master plans and regulatory requirements.
• Participate in risk assessments and change control activities related to engineering systems.
• Support requalification and periodic review programs.

Calibration Management

• Manage calibration schedules for production, utility, laboratory, and engineering instruments.
• Ensure all measuring devices are calibrated according to approved procedures and defined intervals.
• Review calibration certificates and maintain calibration records.
• Coordinate internal and external calibration activities.
• Investigate calibration deviations and support corrective and preventive actions (CAPA).
• Ensure calibration status labeling and traceability are maintained.

Compliance & Quality Support

• Ensure compliance with GMP, GDP, EHS, and pharmaceutical regulatory standards.
• Support internal audits, external audits, and regulatory inspections.
• Participate in deviation investigations, CAPA implementation, and change management.
• Support data integrity and quality risk management initiatives.

Continuous Improvement

• Identify opportunities to improve engineering systems, documentation workflow, and calibration efficiency.
• Support digitalization and automation initiatives within engineering support functions.
• Monitor KPIs related to qualification, calibration, and documentation compliance.

Qualifications

Education

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Mechatronics, Industrial, or related field).

Experience

• 3–5 years of experience in pharmaceutical engineering or technical support functions.
• Strong experience in engineering documentation, qualification, and calibration systems within GMP-regulated environments.