Validation Engineer

The Validation Engineer is responsible for ensuring that manufacturing processes, equipment, and cleaning procedures meet regulatory standards and consistently produce high-quality products. The engineer will design, execute, and document validation activities for cleaning processes, manufacturing equipment, and production processes.

DUTIES AND RESPONSIBILITIES

Their main duties and responsibilities include:

• Write and revise validation documentation, including protocols, reports, SOPs, and risk assessments.
• Maintain an up-to-date knowledge of industry standards, regulatory requirements, and best practices.
• Participate in internal and external audits as a validation subject matter expert (SME).
• Provide training and support to other departments on validation principles and practices.
• Implement and monitor process improvements and corrective actions.
• Develop, review, and execute cleaning validation protocols and reports for manufacturing equipment, including Clean-in-Place (CIP) systems.
• Determine appropriate cleaning cycles, cleaning agents, and acceptance criteria.
• Perform sampling and testing to verify the effectiveness of cleaning procedures.
• Analyze and interpret cleaning validation data.
• Investigate deviations or out-of-specification results related to cleaning validation.
• Develop and execute process validation protocols to demonstrate process capability and consistency.
• Collaborate with cross-functional teams to identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Perform data analysis and trending to ensure processes remain in a validated state.
• Prepare validation reports and maintain the validation master plan.
• Develop and execute equipment validation protocols (IQ, OQ, PQ) for manufacturing and laboratory equipment.
• Ensure equipment is properly installed, calibrated, and maintained.
• Conduct risk assessments related to equipment and systems.
• Review and approve vendor-supplied documentation.
• Troubleshoot and resolve equipment qualification issues.

KNOWLEDGE, SKILLS, AND ABILITIES

This position requires a solid combination of technical knowledge, practical skills, and inherent abilities. A candidate should be able to work independently, within a team environment, and possess a high level of professionalism.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum of 5 years of experience in validation within a regulated industry (pharmaceutical, biotechnology, medical device, etc.).
• Thorough knowledge of cGMP regulations and guidelines.
• Experience with cleaning validation, process validation, and equipment validation.
• Proficiency in data analysis and statistical methods.

SPECIAL FACTORS/WORKING ENVIRONMENT

TRAVEL

Travel may be required for this position.

Mid-Senior level

Full-time

Engineering and Manufacturing

Pharmaceutical Manufacturing