CQV Engineer

• Develop and execute validation protocols (IQ OQ PQ) for equipment facilities utilities and systems. Perform qualification and validation activities according to GMP regulations company procedures and industry standards.
  
• Support the installation commissioning qualification and validation of equipment systems and production lines.
  
• Support the design development and implementation of automation solutions to improve efficiency and reliability in processes. Validate and verify automated systems to ensure functionality and compliance with regulatory requirements.
  
• Generate required validation documentation including protocols master plans summary reports risk analyses SOPs verification documentation etc.
  
• Provide technical support for operations troubleshooting equipment issues and implementing corrective actions.
  
• Support quality assurance activities including deviation investigations change control assessments and CAPA implementation.
  
• Coordinate with crossfunctional teams including engineering quality assurance and operations to ensure alignment and successful execution of validation activities.
  
• Identify and implement continuous improvement opportunities to enhance the efficiency and effectiveness of validation processes.
  
• Additional responsibilities as required.
  

Requirements

• Bachelors degree in related engineering discipline.
  
• 35 years of commissioning qualification and validation experience in the pharmaceutical industry.
  
• Strong knowledge of regulatory standards and industry compliance.
  
• Proven technical skills in equipment installation automation and validation methodologies.
  
• Strong understanding of quality and risk management principles and methodologies.
  
• Ability to interpret technical requirements design specifications user requirement specifications etc.
  
• Excellent technical writing skills; proven experience developing validation protocols and reports.
  
• Excellent problemsolving abilities and attention to detail in executing validation protocols and troubleshooting technical issues.
  
• 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