Process Validation Engineer

Process Validation EngineerELIQUENT 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.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 projectsSupport Process Performance Qualification (PPQ) studies and validation activitiesCoordinate and evaluate aseptic media fill runsPerform revalidation activities for pre-filled syringe (PFS) fill linesSupport tech transfer projects across new and existing manufacturing linesConduct risk assessments and ensure cGMP complianceSupport CQV, qualification, and validation documentation activitiesConduct and support smoke studies for aseptic processing environmentsSupport qualification of automated visual inspection systemsRequired Skills:Process ValidationValidation Protocol Development & ExecutionSmoke StudiesPharmaceutical Manufacturing ExperiencecGMP KnowledgeStrong Documentation & Communication SkillsPreferred Skills:PPQ ExperiencePre-Filled Syringe (PFS) Fill Line ExperienceMedia Fill SupportCQV / Qualification ExperienceTech Transfer ExperienceAutomated Visual Inspection QualificationBenefits: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. Eliquent Life Sciences