Key Responsibilities

Lead and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

Develop and review validation protocols, test scripts, summary reports, and technical documentation.

Support commissioning and qualification (C&Q) of equipment, utilities, and automated systems.

Ensure all validation activities comply with cGMP , FDA , ICH , and EU regulatory requirements.

Partner with Engineering, Quality, Operations, and Automation teams to ensure successful project execution and system readiness.

Utilize electronic validation systems such as Kneat , G-Vault , or similar platforms to manage validation workflows.

Troubleshoot issues during commissioning or qualification and provide technical expertise to resolve deviations.

Maintain audit-ready documentation and support internal/external regulatory audits as needed.

Coordinate validation timelines, deliverables, and resources to support project schedules.

Required Qualifications

Bachelor’s or Master’s degree in Engineering , Life Sciences , or a related field.

Minimum 7+ years of validation experience in pharmaceutical or biotech manufacturing.

Strong expertise in DQ/IQ/OQ/PQ methodologies.

In-depth knowledge of cGMP , FDA , ICH , and EU regulatory expectations.

Proven experience in commissioning and qualification of automated systems, process equipment, and utilities .

Hands-on proficiency with validation platforms such as Kneat , G-Vault , or equivalent systems.

Excellent communication, technical writing, and project coordination skills.

Strong attention to detail and ability to work in a fast-paced, compliance-driven environment.

Preferred Qualifications

Experience in sterile manufacturing, fill-finish, or biologics operations.

Familiarity with risk-based validation approaches (e.g., ASTM E2500, ICH Q9).

Knowledge of data integrity principles and electronic records management.