Process Validation Engineer (Contract)

Process Validation Engineer

Overview

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

This is a contract role with strong potential for extension. The selected consultant should be capable of supporting immediate media-fill activities and/or helping the site build and strengthen its lifecycle process-validation program. Remote-only candidates will not be considered.

Key Responsibilities

·       Develop, author, review, and execute lifecycle process-validation protocols 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, intervention assessment, deviation follow-up, data review, and final reporting.

·       Assess the current process-validation program, identify gaps, and develop practical roadmaps, procedures, templates, and governance needed to establish and sustain a compliant program.

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

·       Analyze and trend manufacturing and validation data to demonstrate process consistency and support an ongoing state of control.

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

·       Lead or support deviations, investigations, CAPAs, and change controls associated with process validation and media-fill execution.

·       Support process transfer, scale-up, new-product introduction, and manufacturing changes by defining appropriate validation requirements and deliverables.

·       Ensure validation activities align with applicable FDA process-validation guidance, 21 CFR Parts 210/211, EU GMP Annex 1, ICH guidance, and site procedures.

Qualifications

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

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

·       Direct experience in sterile or aseptic pharmaceutical manufacturing is required.

·       Demonstrated hands-on experience 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 of PPQ, CPV, risk-based validation, protocol/report writing, data analysis, and applicable process-validation and aseptic-processing guidance.

·       Excellent technical writing and communication skills, with the ability to work independently, lead cross-functional activities, and maintain audit-ready documentation.

·       Radiopharmaceutical or biologics manufacturing experience is a strong plus. Candidates whose experience is limited primarily to equipment IQ/OQ/PQ are not the target for this role.

Details

·       Start Date: ASAP or within 2-3 weeks

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

·       Location: Primarily onsite in Indianapolis, IN. Local candidates are preferred; non-local candidates must be willing to travel regularly to the site. Limited hybrid flexibility may be considered based on project needs, and travel support may be available.

·       Compensation: Competitive hourly rate based on experience