Process Validation Engineer in Los Angeles

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Job DescriptionJob Description

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 focuses on designing, executing, and documenting validation protocols to confirm that processes operate within defined parameters and yield reliable, reproducible results. The engineer collaborates closely with cross-functional teams including quality assurance, manufacturing, and regulatory affairs to identify potential risks and implement corrective actions. A key outcome of this role is to maintain compliance with FDA regulations and Good Manufacturing Practices (GMP), thereby supporting product safety and efficacy. Ultimately, the Process Validation Engineer contributes to continuous process improvement and supports the company’s commitment to delivering high-quality products to the market.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Proven experience in process validation within a regulated manufacturing environment.
• Strong knowledge of FDA regulations and Good Manufacturing Practices (GMP).
• Demonstrated expertise in Failure Modes and Effects Analysis (FMEA).
• Excellent technical writing skills for preparing validation protocols and reports.

Qualifications:

• Advanced degree in Engineering or related discipline.
• Experience with liquid handling systems and equipment validation.
• Familiarity with statistical analysis tools and software used in process validation.
• Certification in quality or validation engineering (e.g., ASQ Certified Quality Engineer).
• Experience working in the pharmaceutical or biotechnology manufacturing industry.

Responsibilities:

• Develop, review, and execute process validation protocols and reports in compliance with FDA regulations and GMP standards.
• Conduct Failure Modes and Effects Analysis (FMEA) to identify and mitigate risks associated with manufacturing processes.
• Collaborate with manufacturing and quality teams to ensure proper implementation of liquid handling procedures and equipment validation.
• Prepare detailed technical documentation and validation reports to support regulatory submissions and internal audits.
• Monitor process performance data and recommend improvements to enhance process robustness and product quality.

Skills:

The required skills such as Failure Modes and Effects Analysis (FMEA) are applied daily to proactively identify potential process failures and implement risk mitigation strategies. Knowledge of FDA regulations and Good Manufacturing Practices (GMP) ensures that all validation activities comply with stringent regulatory standards, safeguarding product quality and patient safety. Expertise in liquid handling is essential for validating equipment and processes that involve precise fluid transfer, which is critical in many manufacturing operations. Technical writing skills are utilized to create clear, comprehensive validation protocols and reports that document compliance and support regulatory inspections. skills like statistical analysis and industry-specific experience enhance the engineer’s ability to analyze process data effectively and contribute to continuous improvement initiatives.

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