QC Test Method Validation Engineer

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.

We are seeking an experienced consultant to lead the quality control (QC) instrumentation validation and analytical method lifecycle activities within a regulated life sciences environment. This role involves hands-on work with analytical instrumentation, method validation, and data integrity to ensure compliance with global regulatory expectations. 

Essential Duties and Responsibilities: 

• KNEAT experience (electronic validation system)
• Develop and execute test method transfers/validation/verification protocols for QC Methods. Examples include:
  • HPLC methods
  • Osmolality assay
  • SDS Page assay
• Develop method SOPs for multiple materials
• Demonstrated method troubleshooting capability
• Validation of quality control instruments (spectrometers) including the following:
  • Review and update User Requirements Specifications (URS) and generate system design and configuration specifications
  • Review and update instrument operations and maintenance Standard Operating Procedures (SOPs)
  • Manage/support vendor instrument IOQ process and develop/executeappropriate PQprotocols
  • Author PQ final reports including trace matrices and data integrity assessments

Requirements: 

• Bachelor’s Degree or superior
• Method development and method validation
• 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
• Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices
• Strong experience with ICH Q2 method qualification/validation requirements, USP, EP, and JP Pharmacopeia
• Hands-on analytical instrumentation experience is preferred
• Knowledge of Good Manufacturing Practices (also cGMP) compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques
• Strong verbal and written communication skills

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.