Unknown Company

Validation Engineer / CQV

round lake, il • Posted 2 days ago
Onsite Contract General

Validation Engineer / CQVAre you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Validation Engineer / CQV. Position Type:ContractOn-SiteRequired:Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related discipline.3 - 10 years of experience in CQV, Validation, or Pharmaceutical Manufacturing environments.Hands-on experience with equipment qualification (IQ/OQ/PQ) in regulated GMP facilities.Experience qualifying manufacturing equipment, autoclaves, washers, filling systems, and laboratory equipment.Knowledge of temperature mapping and qualification methodologies.Understanding of GxP regulations and validation lifecycle principles.Experience reviewing and approving validation documentation and SOPs.Strong technical writing and execution skills.Preferred:Experience in both sterile and non-sterile pharmaceutical manufacturing environments.Familiarity with Validation Master Plans (VMPs).Process Validation experience.Cleaning Validation experience.Previous consulting or project-based validation experience preferred.Responsibilities:Support commissioning, qualification, and validation activities for a new GMP facility and manufacturing areas.Author, review, and execute validation deliverables including MVPs, Validation Plans, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.Perform cleanroom qualification activities including airflow visualization, room recovery testing, differential pressure verification, and environmental monitoring support.Execute qualification activities for autoclaves, parts washers, glassware washers, CTUs, process equipment, and associated utility systems.Perform temperature mapping studies for refrigerators, freezers, incubators, stability chambers, warehouses, and other controlled temperature storage areas.Support qualification of facility and utility systems including HVAC, WFI, clean steam, compressed gases, and other GMP utilities.Investigate protocol deviations, discrepancies, and validation issues; support impact assessments, root cause investigations, and CAPA activities.Review, revise, and author SOPs, work instructions, and other controlled GMP documentation to support startup and operational readiness.Work closely with Engineering, Facilities, Quality, Manufacturing, and vendors to support project timelines and qualification activities.Support change controls, commissioning turnover packages, punch list resolution, and validation lifecycle activities as required.Ensure all qualification and validation activities are performed in accordance with GMP requirements, site procedures, and project schedules.Get in Touch: We want to hear from you!

If you think you'd be a good match, submit your resume and reach out to Priyanshu at to learn more.

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