Validation Engineer

• 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

• Bachelors 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.
  
• Indepth 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.)
  
• Detailoriented 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 problemsolve 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.