Process Validation Engineer

The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes are robust, reliable, and capable of producing high-quality outputs. The engineer will collaborate closely with cross‑functional teams including manufacturing, quality assurance, and research and development to identify process improvements and troubleshoot issues.

A key outcome of this role is to provide comprehensive validation reports and technical documentation that support regulatory submissions and internal quality audits. Ultimately, the Process Validation Engineer ensures that manufacturing processes are optimized for efficiency, compliance, and product safety within the manufacturing environment in the United States.

• Bachelor’s degree in Engineering, Biotechnology, or a related scientific discipline.
• Proven experience in process validation within a manufacturing environment, preferably in the pharmaceutical or biotech industry.
• Strong technical writing skills with the ability to produce clear, concise, and comprehensive validation documentation.
• Strong Technical Writing background
• FMEA experience
• Hands‑on experience with ELISA (Enzyme‑Linked Immunosorbent Assay) techniques and data interpretation.
• Familiarity with regulatory requirements such as FDA, ISO, and cGMP guidelines.