Validation Engineer

The Validation Engineer will be responsible for supporting qualification and validation activities across various systems and processes within the organization. This role ensures that all equipment, utilities, and processes comply with industry regulations and quality standards, working closely with cross-functional teams to drive validation projects from concept through final approval.

Duties and Responsibilities:

• Develop, review, and execute validation protocols (IQ, OQ, PQ) for equipment, systems, utilities, and processes.
• Conduct commissioning and qualification activities for new equipment, utilities, and facility expansions.
• Perform process validation for new products, processes, and cycles to ensure compliance with regulatory and company standards.
• Carry out validation maintenance to assess and ensure the continued performance of existing equipment and systems.
• Investigate and resolve process test failures, contributing to process improvement and efficiency initiatives.
• Review system requirements and specifications to gain in-depth process knowledge and support validation activities.
• Initiate process capability and parameter studies to support validation projects.
• Collaborate with cross-functional teams to ensure project timelines and validation requirements are met.
• Support continuous improvement of validation processes and ensure alignment with regulatory requirements (GMP, FDA, etc.).
• Ensure compliance with applicable industry standards such as GAMP 5, CFR Part 11, and ALCOA+ principles.

Qualifications

• Four-year college degree in Chemistry, Engineering, or a related science (or equivalent combination of education and experience) required
• Strong interpersonal/group communication skills with the ability to collaborate with various peers and stakeholders in support of the manufacturing effort or project team as applicable
• Proficient with current word processing, spreadsheet, and database software
• Understanding and use of basic statistical analysis tools