CQV Engineer

• Draft review and execute commissioning qualification and validation protocols for a range of required equipment and systems.
  
• Schedule and execute qualification activities.
  
• Draft review author and deploy all required validation documentation including IQ/OQ/PQ protocols reports master plans risk assessments operating procedures URS FRS and so on.
  
• Document and report all validation activities and results. Ensure documentation updates as needed.
  
• Perform risk assessments and develop mitigation strategies for equipment and processes as required.
  
• Analyze test results data and acceptance criteria to ensure accuracy.
  
• Ensure all validation and qualification activities are completed in compliance with industry standards and regulations.
  
• Attend meetings and coordinate project activities.
  
• Collaborate closely with crossfunctional teams to ensure alignment and successful project/deliverable .
  
• Additional responsibilities as required.
  

Requirements

• Bachelors degree in related engineering discipline.
  
• 35 years of commissioning qualification and validation experience in the pharmaceutical manufacturing industry.
  
• Handson experience with IQ OQ PQ including equipment like chambers refrigerators fill lines etc.
  
• Strong knowledge of aseptic process and techniques.
  
• Strong knowledge of industry regulations and requirements.
  
• Excellent technical writing skills and experience with full life cycle validation documentation.
  
• Excellent communication and interpersonal skills.
  
• Strong analytical and problemsolving 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
  
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more).
  
• Financial Perks and Discounts