Process Validation Engineer (Contract)
- Compensation
- Not disclosed
- Location
- Indianapolis, United States
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 5+ years
- Category
- Industrial engineering
- Posted
Skills
Must have
- · 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 sit
- · 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 bas
- · Compensation: Competitive hourly rate based on experience
Full description
**Process Validation
EngineerOverview**
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.