Process Validation Engineer (Contract)

Process ValidationEngineer

Overview

Our client, an innovative and fast-growingradiopharmaceutical manufacturing company, is seeking an experienced Process Validation Engineer to supportsterile and aseptic manufacturing operations at its Indianapolis site. This isa hands-on process-validation role focused on media fills, process performancequalification, and maintaining validated processes in a cGMP environment.

This is a contractrole with strong potential forextension. The selected consultant should be capable of supporting immediatemedia-fill activities and/or helping the site build and strengthen itslifecycle process-validation program. Remote-onlycandidates will not be considered.

KeyResponsibilities

·Develop, author,review, and execute lifecycle process-validationprotocols and reports, including process performance qualification (PPQ),continued process verification (CPV), and revalidation activities.

·Plan and support aseptic process simulations/media fills,including protocol development, execution coordination, interventionassessment, deviation follow-up, data review, and final reporting.

·Assess the currentprocess-validation program, identify gaps, and develop practical roadmaps,procedures, templates, and governance needed to establish and sustain acompliant program.

·Define and documentcritical quality attributes, critical process parameters, sampling plans,acceptance criteria, and risk-based validation strategies.

·Analyze and trendmanufacturing and validation data to demonstrate process consistency andsupport an ongoing state of control.

·Collaboratecross-functionally with Manufacturing, Quality, MS&T/Process Engineering,Microbiology, and Regulatory teams to plan and execute validation activities.

·Lead or supportdeviations, investigations, CAPAs, and change controls associated with processvalidation and media-fill execution.

·Support processtransfer, scale-up, new-product introduction, and manufacturing changes bydefining appropriate validation requirements and deliverables.

·Ensure validationactivities align with applicable FDA process-validation guidance, 21 CFR Parts210/211, EU GMP Annex 1, ICH guidance, and site procedures.

Qualifications

·Bachelor's degree inEngineering, Life Sciences, or a related technical field.

·Minimum 5 years of hands-on validation experience in pharmaceutical or biotechnology manufacturing, with meaningfulresponsibility for process-validation deliverables.

·Direct experience in sterile or aseptic pharmaceuticalmanufacturing is required.

·Demonstrated hands-onexperience with at least one of the following is required: (1) planning or executing media fills/aseptic process simulations, or(2) developing or significantly improving a site process-validation program.Experience in both areas is strongly preferred.

·Strong knowledge ofPPQ, CPV, risk-based validation, protocol/report writing, data analysis, andapplicable process-validation and aseptic-processing guidance.

·Excellent technicalwriting and communication skills, with the ability to work independently, leadcross-functional activities, and maintain audit-ready documentation.

·Radiopharmaceuticalor biologics manufacturing experience is a strong plus. Candidates whoseexperience is limited primarily to equipment IQ/OQ/PQ are not the target forthis role.

Details

·Start Date: ASAPor within 2-3 weeks

·Duration: 6-12months, with strong potential to extend

·Location: Primarilyonsite in Indianapolis, IN. Local candidates are preferred; non-localcandidates must be willing to travel regularly to the site. Limited hybridflexibility may be considered based on project needs, and travel support may beavailable.

·Compensation: Competitivehourly rate based on experience