Process Validation Engineer
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Eliquent Life Sciences, Inc
Greenville, NC, US
Summary
Develop and execute process validation strategies for new pharmaceutical fill lines and support Process Performance Qualification (PPQ) studies. Coordinate aseptic media fill runs, conduct risk assessments, and ensure cGMP compliance across manufacturing lines.
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.
We are seeking a Process Validation Engineer to support pharmaceutical manufacturing projects, including a new fill line implementation and revalidation activities.
Key Responsibilities:
• Develop and execute process validation strategies for new fill line projects
• Support Process Performance Qualification (PPQ) studies and validation activities
• Coordinate and evaluate aseptic media fill runs
• Perform revalidation activities for pre-filled syringe (PFS) fill lines
• Support tech transfer projects across new and existing manufacturing lines
• Conduct risk assessments and ensure cGMP compliance
• Support CQV, qualification, and validation documentation activities
• Conduct and support smoke studies for aseptic processing environments
• Support qualification of automated visual inspection systems
Required Skills:
• Process Validation
• Validation Protocol Development & Execution
• Smoke Studies
• Pharmaceutical Manufacturing Experience
• cGMP Knowledge
• Strong Documentation & Communication Skills
Preferred Skills:
• PPQ Experience
• Pre-Filled Syringe (PFS) Fill Line Experience
• Media Fill Support
• CQV / Qualification Experience
• Tech Transfer Experience
• Automated Visual Inspection Qualification
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.
We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products.
Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape.
From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust.
Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges.
Learn more at ELIQUENT.com
Company size
501-1,000 employees
Industry
Professional Services
Org type
Privately Held
We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products.
Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape.
From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust.
Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges.
Learn more at ELIQUENT.com
Company size
501-1,000 employees
Industry
Professional Services
Org type
Privately Held
