Validation Engineer

Responsibilities:

• Qualification Activities: Lead qualification efforts for utilities, equipment, and laboratory systems, including but not limited to clean utilities, autoclaves, washers, fillers, laboratory instruments, and controlled temperature units.
• Client Interaction: Provide validation support to clients, including assistance with customer product launches and the qualification of new equipment.
• Capital Projects Oversight: Support and oversee validation activities related to capital expansion projects and facility build-outs.
• Documentation Ownership: Develop, update, and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines for equipment validation, including policies, standards, procedures, and templates.
• Facility Change Review: Assess facility modifications and provide input on the re-validation and re-qualification of equipment.
• Risk Management: Evaluate and mitigate risks associated with equipment-related processing steps, ensuring comprehensive validation requirements and deliverables are met.
• Collaboration: Work closely with cross-functional teams, including Engineering and Operations, to support and monitor validation and process improvement initiatives.
• Protocol Compliance: Execute validation qualifications in line with relevant protocols and identify and address any protocol deviations.
• Industry Awareness: Stay informed on current validation industry trends and regulatory expectations, recommending updates to ensure program alignment with evolving standards.

Qualifications:

• Bachelor’s degree or higher in a STEM discipline.
• 5-8 years of experience in validation or a related field.
• At least 4 years of GMP or other regulated industry experience required.
• Ability to work onsite and perform physical tasks as necessary.