Validation Engineer

Primary Responsibilities

• Develop, execute, and maintain validation protocols for bioprocessing equipment, systems, and processes to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements (FDA, EMA, ICH).

• Perform qualification activities (IQ, OQ, PQ) for bioreactors, chromatography systems, filtration units, and other critical biopharma equipment to ensure operational reliability and compliance.

• Collaborate with cross-functional teams, including process engineering, quality assurance, and manufacturing, to design and implement validation strategies for new and existing processes.

• Prepare and maintain comprehensive validation documentation, including validation plans, protocols, reports, and standard operating procedures (SOPs), to support regulatory audits and inspections.

• Conduct risk assessments and gap analyses to identify and mitigate potential validation issues, ensuring product quality and patient safety.

• Support process validation by analyzing data to verify that bioprocesses consistently produce products meeting predefined specifications and quality attributes.

• Lead or assist in the investigation of deviations, non-conformances, and out-of-specification results, developing corrective and preventive actions (CAPAs) to address root causes.

• Ensure compliance with Current Good Manufacturing Practices (cGMP) and other regulatory standards by maintaining up-to-date knowledge of industry guidelines and best practices.

• Provide technical expertise and training to manufacturing and quality teams on validation requirements and procedures.

• Manage validation schedules and project timelines to ensure timely completion of qualification and validation activities.

• Support technology transfer and scale-up activities by validating processes and equipment during transitions from development to commercial production.

• Participate in internal and external audits, providing validation documentation and addressing regulatory inquiries as needed.

• Monitor and report on validation performance metrics to ensure continuous improvement and compliance with organizational and regulatory standards.

• Perform additional duties as assigned to support biopharma operations and quality objectives.

Secondary Responsibilities

• Assist in the selection and qualification of new equipment, systems, or technologies to enhance bioprocessing capabilities.

• Maintain accurate and organized records of validation activities, ensuring traceability and readiness for regulatory submissions.

• Coordinate with vendors and suppliers to obtain necessary documentation, such as equipment manuals or calibration certificates, to support validation efforts.

• Provide backup support to other departments, such as quality control or process engineering, during high-demand periods or special projects.

• Contribute to the development of long-term validation strategies to support operational scalability and regulatory compliance.

• Foster effective communication with cross-functional teams to align on validation objectives, timelines, and regulatory expectations.