Clark & Enersen · 7 hours ago
Process Validation Engineer
Los Angeles, CA
Full-time
Onsite
Mid Level
$60/hr - $70/hrClark & Enersen is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet quality standards and regulatory requirements by designing, executing, and documenting validation protocols.
Consulting
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
Qualification
Required
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
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
Company
Clark & Enersen
Clark & Enersen was founded in 1946 in by Architect Kenneth B. Clark and Landscape Architect Lawrence A.
Founded in 1946
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase