Validation Engineer

W2 only, no C2C, must be authorized to work in the US (both now and in the future).

Validation Engineer (Direct Hire) - in Verona, WI. Apply now for this opportunity at Carex!

Carex is partnering with a biopharmaceutical industry partner to hire a Validation Engineer to support commissioning, qualification, and validation (CQV) efforts at a GMP drug substance manufacturing site. This role is critical in ensuring equipment, utilities, facilities, and processes meet internal and regulatory standards through science- and risk-based validation practices.

What You’ll Do

• Develop and maintain site Validation Master Plans, CQV protocols, and equipment qualification templates.
• Lead cross-functional teams in performing system impact evaluations and risk assessments in a multi-product GMP environment.
• Conduct gap assessments and implement remediation actions for new equipment or product introductions.
• Assist in developing and maintaining User Requirements Specifications.
• Prepare and execute IQ/OQ/PQ protocols for pharmaceutical manufacturing equipment, utilities, and automation systems.
• Oversee completion of validation studies in collaboration with subject matter experts.
• Provide validation support for process, cleaning, and instrument qualification studies.
• Review and approve CQV reports and assess change controls for qualification impact.
• Manage requalification activities and track periodic reviews in alignment with GMP compliance standards.
• Maintain validation documentation for audit readiness and regulatory inspections.
• Collaborate cross-functionally to meet project milestones, resolve deviations, and support continuous improvement.
• Perform other related duties as assigned.
  
  
  

What You’ll Bring

• Bachelor’s degree in Engineering or a related scientific discipline.
• 8 years of validation engineering experience, preferably in pharmaceutical drug substance manufacturing.
• Ability to interpret engineering drawings such as P&IDs and electrical schematics.
• Strong knowledge of cGMP and FDA regulations.
• Proven documentation, communication, and project management skills.
• Experience qualifying equipment using ISPE and ASTM methodologies.
• Proficiency in Microsoft Office Suite.
  
  
  

Preferred Qualifications

• Experience qualifying automated or shared equipment in multi-product environments.
• Familiarity with ISPE Baseline Guide 5, Volume 2.
• Understanding of software validation under a computer software assurance (CSA) model.
• Experience with cleaning and process validation for pharmaceuticals.
• Familiarity with Blue Mountain Regulatory Asset Manager software.
  
  
  

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.