Process Validation Engineer

Eliquent Life Sciences, Inc • Los Angeles, CA

7h

About The Position

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.

Requirements

• 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.
• Hands-on experience with ELISA (Enzyme-Linked Immunosorbent Assay) techniques and data interpretation.
• Familiarity with regulatory requirements such as FDA, ISO, and cGMP guidelines.

Nice To Haves

• Advanced degree (Master’s or PhD) in Engineering, Life Sciences, or related field.
• Experience with statistical analysis software and process control tools.
• Knowledge of automation and process analytical technology (PAT) applications.
• Certification in quality or validation engineering (e.g., ASQ Certified Quality Engineer).
• Previous experience working in a highly regulated manufacturing environment within the United States.

Responsibilities

• Develop, review, and execute process validation protocols and reports in compliance with industry standards and regulatory guidelines.
• Perform risk assessments and root cause analyses to identify potential process failures and implement corrective actions.
• Collaborate with manufacturing and quality teams to design experiments and validation studies, including ELISA-based assays where applicable.
• Prepare detailed technical documentation and validation summaries to support regulatory submissions and internal audits.
• Monitor process performance data and recommend continuous improvement initiatives to enhance process capability and product quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees