Validation Engineer

Responsibilities:

• Perform qualification activities for utilities, equipment, and systems, ensuring proper functionality and compliance. This includes, but is not limited to, utilities, sterilization equipment, processing equipment, laboratory instruments, and controlled storage units.
• Collaborate with clients to provide validation support for new product launches, equipment installations, and related projects.
• Support and oversee validation efforts for facility expansion and capital improvement projects.
• Contribute to the creation and maintenance of validation documentation, including templates, strategies, and standard operating procedures.
• Review and assess changes to facilities and equipment, recommending necessary re-validation or re-qualification as needed.
• Identify and assess risks related to equipment and processes, and contribute to the development and review of validation requirements and specifications.
• Work closely with cross-functional teams, including Engineering and Operations, to support validation and process improvement initiatives.
• Conduct validation qualifications according to established protocols and identify any deviations or non-conformances.

Qualifications:

• Bachelor’s degree or higher in a relevant technical field.
• 2-4 years of experience in validation or a related field.
• At least 2 years of experience in a regulated industry, such as GMP or similar.
• Physically able to work onsite in various environmental conditions.

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