Job Description

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.

Key Responsibilities:

• Develop, execute, and manage process validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with cross-functional teams to gather necessary data for validation activities and ensure adherence to regulatory requirements and industry standards.
• Conduct process mapping and risk assessments to identify critical process parameters (CPP) and critical quality attributes (CQA).
• Analyze data from process runs to ensure stability and consistency of processes, identifying trends and patterns that may affect quality.
• Document validation processes in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Review and approve validation documentation, including reports, protocols, and related SOPs.
• Support change control processes and manage validation lifecycle activities.
• Provide training and guidance to staff on validation standards and practices.
• Act as a key liaison during internal and external audits, ensuring compliance with validation processes and documentation.

Requirements

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 4-7 years of experience in process validation within the pharmaceutical or biotechnology industry.
• In-depth knowledge of process validation guidelines, including 21 CFR Part 211, ISPE, and ASTM E2500.
• Familiarity with statistical analysis tools and methodologies for validation.
• Strong analytical skills with a detail-oriented approach.
• Excellent communication skills, both verbal and written, to effectively collaborate with diverse teams.
• Ability to work independently and manage multiple projects under tight deadlines.

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.

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