Specialist – Engineering (Documentation & Validation Execution)

About the role

This role involves preparation and review of qualification documents including User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities and facility in compliance with regulatory guidelines. You will execute qualification and validation activities across process, cleaning, computer systems, equipment, utilities, and facilities, while coordinating with cross-functional teams and external service providers to maintain equipment, systems, and processes in validated state.

Key responsibilities

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines
• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility
• Preparation and review of process and cleaning validation protocols and reports
• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state
• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes
• Write, review, and revise validation SOPs in compliance with regulatory guidelines
• QA oversight and/or review during the validation process
• Manage incidents and deviations related to validation & qualification
• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation
• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies

About you

• Degree in a scientific discipline or equivalent
• A minimum of 5-7 years' relevant experience in pharmaceutical manufacturing environment
• Knowledge and experience of qualification/validation principles and their practical application
• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer
• Familiarity with regulatory/compliance environment
• Ability to interact and lead effectively in a team-based environment
• Experience in a regulated industry preferred