Quality Engineer, CAPAs and Deviations

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.

As a Quality Engineer, you will play a critical role in supporting our clients' quality systems by leading and facilitating investigations, managing deviations, and driving CAPA (Corrective and Preventive Actions) processes. You will be responsible for conducting root cause analysis, reviewing deviation records, and identifying systemic issues to enhance manufacturing quality. This role requires a strong understanding of cGMP, single-use mammalian product manufacturing, and experience with CIP (Clean-in-Place) and SIP (Steam-in-Place) systems.

Key Responsibilities:

• Lead and conduct thorough investigations into deviations, non-conformances, and quality events in a GMP environment.

• Perform and document root cause analysis using industry-standard tools (e.g., 5 Whys, Fishbone diagrams).

• Review deviation records for completeness, accuracy, and compliance with internal and regulatory standards.

• Drive effective CAPA implementation to address root causes and prevent recurrence.

• Support clients in optimizing their deviation management processes and investigation frameworks.

• Provide subject matter expertise on single-use mammalian product manufacturing processes.

• Collaborate with cross-functional teams including Manufacturing, Quality Assurance, and Validation.

• Evaluate and recommend improvements to CIP and SIP systems related to cleaning validation and contamination control.

• Ensure compliance with FDA, EMA, and global regulatory standards.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.

• 3+ years of experience in a Quality Engineering or similar role in the biopharmaceutical or pharmaceutical industry.

• Proven experience conducting investigations, managing deviations, and leading CAPA activities.
• Excellent analytical, problem-solving, and documentation skills.

• Experience with root cause tools and techniques.

• Strong communication skills and ability to work in a consulting or client-facing environment.

Preferred Qualifications but not 100% required:

• Provide subject matter expertise on single-use mammalian product manufacturing processes.
• Evaluate and recommend improvements to CIP and SIP systems related to cleaning validation and contamination control.
• Advanced degree or certifications in Quality or Regulatory Affairs.

• Experience working in a consulting or project-based environment.

• Knowledge of quality systems software (e.g., TrackWise, Veeva).

Hourly Range: $50-$65/hr

Benefits

What We Offer:

• Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience.
• Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
• Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.