Lead and execute validation activities, including equipment, process, cleaning, and computer system validation (CSV) in compliance with industry standards and regulatory requirements.
Develop, review, and approve validation protocols, reports, and procedures for new and existing systems and equipment.
Ensure that all validation documentation is completed in a timely manner, ensuring compliance with GMP, FDA, and other regulatory guidelines.
Perform risk assessments and ensure appropriate validation strategies are implemented for critical systems and processes.
Participate in the qualification of new equipment, facilities, and systems, ensuring that they meet all regulatory and quality standards.
Coordinate and manage cross-functional teams to support validation activities across manufacturing, engineering, and quality departments.
Review and approve change controls related to validated systems, ensuring that any changes are appropriately evaluated and documented.
Lead investigations into deviations, non-conformances, and other validation-related issues, ensuring root cause analysis is conducted and corrective actions are implemented.
Collaborate with internal teams to ensure validation requirements are met for new product introductions and changes to existing products.
Provide mentorship and guidance to junior validation engineers and other team members as needed.
Maintain a thorough understanding of current industry practices and regulatory requirements, ensuring compliance with the latest guidelines (e.g., FDA, EMA, ICH).
Support the preparation for regulatory inspections and audits, ensuring all validation-related documentation is audit-ready.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related field.
4-5 years of experience in validation within the pharmaceutical industry.
Strong knowledge of validation practices, GMP, FDA, and other regulatory requirements (e.g., ICH, EMEA).
Experience with equipment qualification (IQ, OQ, PQ), process validation, cleaning validation, and computer system validation (CSV).
Knowledge of risk management principles and application in validation activities.
Proficiency in validation documentation, including protocols, reports, and change control processes.
Experience with validation software and tools (e.g., TrackWise, LIMS, SAP) is a plus.
Familiarity with regulatory inspection processes and experience preparing for FDA or other regulatory audits.