Validation Engineer (Contract)

Overview

Our client, an innovative and fast -growing pharmaceutical manufacturing company, is seeking an experienced Equipment Validation Engineer to support validation efforts across its cGMP manufacturing and laboratory operations. This role offers the opportunity to contribute to high -impact projects in a cutting -edge, regulated environment focused on therapeutic production.

This is a contract role with strong potential for extension. Local candidates are preferred, but hybrid arrangements may be considered for candidates willing to travel on -site to Indianapolis 2–3 days per week.

Key Responsibilities

• Author, review, and execute IQ/OQ/PQ protocols for a range of GMP manufacturing and laboratory equipment.
  

• Support commissioning, qualification, and validation of new and existing equipment including:
  

  • Cleanroom and HVAC systems
    

  • Bioprocessing and fill/finish equipment
    

  • Laboratory instruments
    

  • Radiation shielding and containment systems
    

• Collaborate cross -functionally with Engineering, Quality, Manufacturing, and Regulatory teams to ensure validation activities align with project timelines and compliance standards.
  

• Assist with deviation investigations, change controls, and CAPA implementation related to equipment validation.
  

• Ensure all validation activities comply with FDA, USP, ICH, and cGMP regulatory requirements.
  

• Maintain thorough and audit -ready documentation throughout the validation lifecycle.
  

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
  

• Minimum 3–5 years of hands -on validation experience in the pharmaceutical, biotech, or pharmaceutical industry.
  

• Strong working knowledge of equipment qualification (IQ/OQ/PQ) and relevant regulatory guidance.
  

• Familiarity with GAMP 5, FDA 21 CFR Part 11, and risk -based validation approaches.
  

• Excellent written and verbal communication skills.
  

• Ability to work independently, manage priorities, and contribute in a fast -paced environment.
  

• Experience in pharma, sterile manufacturing, or working with radioactive materials is a plus but not required.
  

Details

• Start Date: ASAP or within 2–3 weeks
  

• Duration: 6–12 months, likely to extend
  

• Location: Hybrid – Onsite 2–3 days/week in Indianapolis, IN (travel support may be available for non -locals)
  

• Compensation: Competitive hourly rate (based on experience)