Process Validation Engineer at Eliquent Life Sciences, Inc – Los Angeles, California

About Company:

Who Are We?

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

Why explore your future at ELIQUENT?

ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.

About the Role:

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.

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

Skills:

The required skills of technical writing and ELISA are integral to the daily responsibilities of the Process Validation Engineer. Technical writing skills are used to create detailed validation protocols, reports, and regulatory documentation that clearly communicate complex technical information to diverse stakeholders. Proficiency in ELISA techniques enables the engineer to design and interpret immunoassays that are often critical for validating biological processes and product quality. Preferred skills such as statistical analysis and knowledge of process control tools support data-driven decision-making and continuous process improvement. Together, these skills ensure that the engineer can effectively validate manufacturing processes, maintain compliance, and contribute to the overall quality and safety of the products.