Process Validation Engineer Consultant

Process Validation Engineer Consultant - 248979

This range is provided by Medix™. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$70.00/hr - $90.00/hr

The Process Validation Consultant will support biologics manufacturing activities with a primary focus on upstream and downstream process validation. This contract role is a backfill for a previous consultant and will play a critical role in executing process validation lifecycle activities, authoring key validation documentation, and supporting cross‑functional teams during periods of heightened activity and audits.

This position is primarily onsite, with limited remote flexibility. Approximately 25% onsite presence is required to support audits and critical project milestones.

• Execute process validation activities across the full validation lifecycle for biologics manufacturing
• Support upstream and downstream manufacturing processes, including chromatography operations and parameter evaluation
• Author and review validation documentation, including Validation Master Plans (VMPs), protocols, reports, risk assessments, and PFMEAs
• Perform data analysis and support validation studies for clinical phase manufacturing (Phase 1–3)
• Collaborate cross‑functionally with manufacturing, quality, and technical operations teams
• Support regulatory inspections and internal audits during “pockets of intensity”
• Ensure validation activities are aligned with current regulatory expectations and industry best practices

• 5–10 years of experience in process validation within biologics manufacturing
• 5–10 years of hands‑on experience authoring and executing Validation Master Plans (VMPs)
• Strong understanding of upstream and downstream biological processes
• In‑depth knowledge of chromatography processes and critical parameter control
• Experience supporting validation activities across clinical phases (Phase 1, 2, and
  3)
• Strong technical writing skills with the ability to produce clear, compliant documentation

• Experience supporting drug substance and/or drug product manufacturing
• Prior consulting or contract experience in regulated biologics environments
• Clear and effective verbal communication
• Strong technical writing and documentation skills
• Ability to work independently while integrating into an established team
• Comfortable working in fast‑paced environments with fluctuating workloads

• Contract length: 6 months, with potential for extension
• Schedule:
  
  40 hours per week

Not Applicable

Full‑time

Pharmaceutical Manufacturing

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