Validation Engineer jobs in Washington, DC

• Develop and execute IQ, OQ, PQ, and PV protocols, test methods, procedures, reports, risk assessments, and so on for a range of pharmaceutical and manufacturing equipment, facilities, utilities, and associated systems. 
  
• Contribute to the development of master plans and validation strategies for a variety of manufacturing processes, adhering to regulatory requirements and compliance. 
• Collaborate with cross functional teams to ensure alignment and successful completion of validation activities and deliverables.
  
• Perform risk assessments and support risk mitigation strategies. Investigate, review, and efficiently close deviations.
  
• Provide support for regulatory inspections as needed. 
  
• Identify potential risks/issues throughout validation lifecycle, effectively supporting change controls. 
  
• Conduct periodic reviews and requalification assessments as needed. 
  
• Ensure all required documentation is reviewed, approved, stored, and managed accurately. 
  
• Collaborate with vendors and contractors to ensure that equipment and systems meet validation requirements and specifications.
  
• ​Drive continuous improvement initiatives to enhance validation processes, documentation practices, and compliance standards across the organization.
  
• Additional responsibilities as required to drive successful project completion. 

Requirements

• Bachelor's degree in relevant engineering discipline. 
  
• 5 years in a equipment commissioning, qualification, and validation engineering role, including proven success developing and executing validation protocols in the pharmaceutical manufacturing industry. 
  
• In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc. 
  
• Experienced with validation of pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems.
  
• Advanced understanding of validation principles and methodologies.
  
• Excellent technical writing skills. 5 years of experience drafting, developing, reviewing, and authoring technical documentation including protocols, procedures, risk assessment, specification requirements, etc. 
  
• Strong understanding of engineering specifications (URS, DS, FS, etc.)
  
• Detail-oriented with a focus on accuracy and compliance.
  
• Ability to manage multiple priorities and prioritize tasks effectively. 
  
• Excellent communication and interpersonal skills.
  
• Strong analytical skills with the ability to problem-solve and troubleshoot effectively.
  
• 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.