Validation Engineer

• Responsible for executing risk assessment and FMEA for assigned products processes and various equipment and systems.
  
• Analyze processes identify risks causes and effects and provide efficient solutions to any potential failures.
  
• Initiates authors revises reviews and completes all required validation documentation.
  
• Generate prepare and execute protocols analyze test results and prepare technical reports with little supervision.
  
• Contribute directly to the completion of validation projects through the development of validation schedules master plans validation protocols and reports.
  
• Support the review and qualification of equipment for commissioning qualification and validation activities.
  
• Collaborate with multiple departments on assigned project activities and deliverables.
  
• Initiate and coordinate risk analyses design reviews execute FAT/SAT IQ OQ and PQ.
  
• Additional duties and responsibilities as assigned.
  

Requirements

• Bachelor s Degree in Engineering or related.
  
• 58 years of validation experience in an aseptic environment.
  
• Strong knowledge and experience with risk assessment processes and FMEA.
• Experience in authoring and executing validation documentation.
  
• Experience in developing SOPS final reports and validation/quality policies.
  
• Experience in equipment and process qualification for compounding filling assembly etc.
  
• Strong understanding of developing executing and maintaining CQV procedures and policies.
  
• Advanced understanding of cGMP guidelines.
  
• Ability to work independently with limited supervision.
  
• Excellent communication skills.
  
• Strong organization skills and attention to detail.
  
• Analytical and problem solving skills.
  
• 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