Validation Engineer jobs in Chicago, IL

• Proactively support commissioning, qualification, and validation activities. Develop and implement comprehensive validation plans.
  
• Develop and execute CQV protocols for required equipment, facilities, utilities, systems, and processes, ensuring compliance with regulatory requirements and industry standards.
  
• Develop and execute validation protocols for required HVAC systems, including IQ, OQ, PQ. Conduct thorough risk assessment related to HVAC system validation. 
  
• ​Investigate and troubleshoot HVAC system deviations, ensuring timely resolution and documentation of corrective actions.
  
• Write, review, and approve technical CQV documentation including standard operating procedures, validation plans, execution plans, risk assessments, summary reports, URS, FRS, design specifications, testing protocols, and so on.
  
• Conduct risk assessments to identify and mitigate potential validation risks. Support investigations, deviations, and change control processes. 
  
• Collaborate with cross-functional teams to ensure alignment on project deliverables and timelines. 
• Additional responsibilities as assigned.
  

Requirements

• Bachelor's Degree in related engineering discipline. 
  
• 3-5 years of hands-on commissioning, qualification, and validation engineering experience in the pharmaceutical/life science industry. 
  
• HVAC system experience is required. 
  
• KNEAT system experience is highly preferred. 
  
• Strong technical writing skills, experienced writing and executing validation protocols, reports, etc. 
  
• Advanced understanding of validation principles and risk-based approaches. 
• Strong knowledge of regulatory requirements and industry standards (cGMP, GDP, FDA, EMA, etc.)
  
• Proficiency in risk assessment methodologies and root cause analysis.
  
• Strong analytical and problem-solving skills, with a meticulous attention to detail.
  
• Excellent communication and interpersonal skills.
  
• Ability to work independently and collaboratively in a fast-paced environment.
  
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.