Validation Engineering

Company DescriptionGxP Associates is a rapidly expanding talent and workforce solutions provider specializing in supporting pharmaceutical, biotechnology, and medical device industries. We enable organizations to maintain compliance and execute critical projects by delivering highly skilled professionals in engineering, quality, validation, regulatory, and IT roles. With a deep understanding of regulated environments, we connect exceptional talent with innovative life sciences companies to drive success. Our flexible delivery models and extensive candidate network ensure tailored solutions for client and partner needs, creating long-term value. At GxP Associates, we prioritize integrity, agility, and industry expertise to cultivate partnerships that foster growth and compliance in the life sciences sector.🔬 Hiring: Validation Engineer – Sterile / Injectable (W2 Contract Only)📍 Location: Rockeymount, NC📅 Duration: 12 Months (Strong Possibility of Extension)💼 Employment Type: Contract (W2 Only)GXP Associates is currently seeking an experienced Validation Engineer – Sterile / Injectable to support aseptic process validation activities for sterile injectable products in a cGMP manufacturing environment.📌 Note: This is a W2 contract role only. C2C and 1099 candidates will not be considered.🔎 Role SummaryThe selected candidate will support aseptic process validation with a strong focus on vial filling and fill-finish operations within a regulated pharmaceutical manufacturing setting.✅ Key ResponsibilitiesSupport aseptic process validation for sterile injectable and vial filling operationsExecute and document media fills, process validations, and cleaning validationsPrepare and review IQ/OQ/PQ protocols and validation reportsSupport aseptic vial filling line validations (filling, stoppering, and capping)Participate in deviation investigations, CAPA, and risk assessmentsEnsure compliance with cGMP, FDA, and regulatory requirementsCollaborate with Manufacturing, QA, and Engineering teams during validation execution🎯 Required Skills & Experience4–8 years of validation experience in sterile injectable manufacturingHands-on experience with aseptic vial filling operationsStrong experience in media fills and fill-finish validationSolid understanding of cGMP and FDA regulationsExcellent documentation and technical writing skills📩 Interested candidates can share their updated resume to:Saikiran@gxpassociates.com