Validation Engineer jobs in Escondido, CA

• Develop, execute, and review validation protocols, ensuring compliance with regulatory requirements and industry standards.
  
• Support the development, writing, and review of specification documentation including URS, FS, and DS. 
  
• Develop and implement construction control plans, ensuring adherence to cGMP and regulatory requirements.
  
• Collaborate with the engineering team to provide validation input during the design phase of projects.
  
• Perform risk assessments and provide guidance to mitigate potential validation issues during construction.
  
• Validate utilities and process equipment to ensure they meet regulatory and company standards, including but not limited to lyophilizers, chrome skids, controlled temperature units, bioreactors, and so on. 
  
• Troubleshoot and resolve validation-related issues with utilities and equipment.
  
• Prepare and maintain comprehensive validation documentation, including protocols, change controls, reports, and standard operating procedures (SOPs).
  
• Conduct factory acceptance testing when required. 
  
• Additional responsibilities as required. 

Requirements

• Bachelor's Degree in engineering or related. 
  
• 3-6 years of experience of validation, commissioning, and qualification engineering experience in the pharmaceutical manufacturing industry. 
  
• Proven experience and success in developing specification documentation including URS, FS, DS, etc.
  
• Background in supporting construction projects.
  
• Experienced conducting factory acceptance testing.
  
• Experienced in project design support, ensuring that validation considerations are integrated into the design and implementation of new systems and processes.
  
• Experienced with utilities and process equipment (lyophilizers, chrome skids, controlled temperature units, tanks, bioreactors, etc.) 
• Advanced knowledge of industry regulations. 
  
• Experience with automation controls is a plus.
  
• Excellent communication and collaboration skills.
  
• Detail-oriented with a focus on ensuring compliance and quality.
  
• 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