CQV Engineer

• Develop and execute document specifications design documentation input configuration installation qualification operational qualification and performance qualification protocols.
  
• Develop and execute test consumables and equipment instrumentation and calibration standards ensuring specifications/requirements and quality regulations are met.
  
• Draft and execute document specifications for Computer System Validation (CSV) and Software Validation.
  
• Provide technical writing expertise to accurately document validation processes and outcomes.
  
• Conduct risk analyses identifying and mitigating any potential risks or issues.
  
• Collaborate with crossfunctional departments to align on project tasks processes and deliverables.
  
• Additional responsibilities as required.
  
  

crm.templates.job.description.requirements

• Bachelors degree in related engineering discipline.
  
• 35 years of validation engineering experience in the pharmaceutical/life science industry including IQ OQ PQ development and execution for a range of equipment systems instrumentation and computerized systems.
  
• Excellent technical writing skills. Proven success in reviewing authoring and developing a range of technical documentation. This includes but is not limited to IQ OQ PQ protocols engineering specifications design documentation input configuration and so on.
  
• Experienced with software protocol development.
  
• Advanced understanding of regulatory standards and guidelines.
  
• Ability to produce clear and concise documentation.
  
• Excellent attention to detail time management and organizational skills.
  
• Strong analytical/problem solving skills.
  
• Familiarity with Information Technology (IT) and Operations Technology (OT) concepts and systems.
  
• Knowledge of hardware equipment and physical attributes for automation lines is a plus.
  
• 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.
  

crm.templates.job.description.benefits

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