CSV Engineer

Purpose The CSV Engineer plays a key role in ensuring the ongoing validation compliance of computerized systems and equipment within a sterile pharmaceutical manufacturing environment. The successful candidate will support the validation lifecycle of computerized systems, maintain compliance with regulatory requirements, and contribute to continuous improvement initiatives across manufacturing and support functions.

Responsibilities

• Support the validation of new computerized equipment, automation systems, and control systems.
• Generate and review validation documentation, including protocols and reports.
• Execute and support validation activities including DQ, IQ, OQ, and PQ.
• Participate in change control processes, providing guidance on Computer System Validation (CSV) requirements.
• Design, implement, and execute validation studies for manufacturing, utility, and control systems.
• Ensure validation activities comply with applicable health and safety, cGMP, environmental, and regulatory requirements.
• Maintain the validated state of computerized systems and equipment through effective lifecycle management.
• Support the development, review, execution, and approval of validation and revalidation plans.
• Review and approve change controls impacting validated systems.
• Provide technical support regarding current FDA, EU GMP, and industry validation requirements.
• Work cross-functionally with Manufacturing, Engineering, Quality, and other support departments to ensure compliance and project success.
• Support inspections and audits as required.

Requirements

• Degree in Science (Chemistry, Microbiology, Pharmacy, or related discipline) or Engineering (Chemical, Mechanical, Electrical, or related discipline).
• Desirable- Postgraduate qualification relevant to validation, engineering, or pharmaceutical manufacturing.
• 3 to 5 years' experience within a healthcare, life sciences, or pharmaceutical manufacturing environment.
• 2 to 3 years' experience in a validation or computer systems validation role.
• Experience managing or supporting technical projects in a regulated environment.
• Experience working with computerized systems used in manufacturing operations.
• Strong understanding of Computer System Validation (CSV) principles and lifecycle management.
• Knowledge of GAMP, ISPE guidance documents, and industry best practices.
• Good understanding of cGMP requirements and pharmaceutical compliance regulations.
• Ability to troubleshoot validation-related issues and drive effective solutions.
• Knowledge of pharmaceutical manufacturing processes and equipment.
• Familiarity with quality management systems, change control, and deviation management.
• Strong project planning and execution skills.
• Effective communication and stakeholder management skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Strong team player with the ability to influence and collaborate across departments.
• Self-motivated, resilient, and results-oriented.
• Adaptable and flexible in a fast-paced regulated environment.
• Pragmatic problem solver with strong analytical skills.
• Ability to manage multiple priorities and deliver projects to completion.
• This role operates within a GMP-regulated pharmaceutical manufacturing facility and requires close collaboration with Manufacturing, Engineering, Quality, Validation, and other support functions to ensure ongoing compliance and operational excellence.