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ELIQUENT Life Sciences · 17 hours ago

Process Validation Engineer

Los Angeles, CA, US

Full-time

Onsite

Mid Level

$60/hr - $70/hr

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions. The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements, collaborating with cross-functional teams to optimize processes and prepare validation documentation.

ConsultingMedical DeviceProfessional Services

H1B Sponsor Likely

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

Process validationELISA techniquesTechnical writingRegulatory requirementsStatistical analysis softwareProcess control toolsAutomation knowledgeQuality engineering certificationManufacturing experience

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

ELIQUENT Life Sciences

ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.

Washington, District of Columbia, USA

501-1000 employees

https://eliquent.com

H1B Sponsorship

ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (29)

2024 (3)

Funding

Current Stage

Late Stage

Leadership Team

Stephen Purtell

Chief Financial Officer

Rob Wojciechowski

Chief Operating Officer

Recent News

Business Wire India

ELIQUENT Life Sciences Announces Strategic Acquisition of Azzur Consulting – Strengthening Full-Service Quality & Compliance Capabilities

2025-05-08

citybiz

ELIQUENT Life Sciences Acquires Azzur Consulting

2025-05-08

globallegalchronicle.com

ELIQUENT Life Sciences’ Acquisition of Truliant Consulting

2025-04-07

Company data provided by crunchbase