KNEAT Engineer

• Lead and perform commissioning, qualification, and validation activities, ensuring compliance with regulatory requirements and industry standards.
  
• Execute the validation of KNEAT as the primary electronic validation and documentation system.
  
• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  
• Demonstrate proficiency in working with the KNEAT platform for efficient and effective management of validation documentation and processes.
  
• Generate comprehensive validation documentation, including summary reports, SOPs, validation plans, deviation/incident reports, and so on.
  
• Maintain accurate and up-to-date records of all validation activities.
  
• Conduct risk assessments and develop mitigation strategies to address identified risks.
  
• Work closely with cross-functional teams, including Quality Assurance, IT, and Operations, to ensure alignment on validation strategies and timelines.
  
• Communicate effectively with internal and external stakeholders to provide updates on validation activities.
  
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards in all validation activities.
  
• Additional responsibilities as required.
  

Requirements

• Bachelors Degree in Engineering or related.
  
• 3-5+ years of KNEAT Validation Engineering experience.
  
• Proven experience with the KNEAT platform is mandatory.
  
• Strong understanding of regulatory requirements and industry standards.
  
• Excellent communication and interpersonal skills.
  
• Detail-oriented with a strong ability to problem-solve and make data-driven decisions.
  
• Adaptable and flexible.
  
• Strong time-management and organizational skills.
  
• Travel is required. 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.
  

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts