Validation Project Manager

• Drive project success by assessing priorities and project plans schedule and budget and ensure timely and effective resolution of potential risks and issues.
  
• Assist in the development of CQV project planning in accordance to project design documentation equipment specifications regulations etc.
  
• Develop review and execute commissioning qualification and validation protocols for required equipment facilities utilities and systems.
  
• Conduct risk assessments and develop mitigation strategies for validation projects. Identify document and manage deficiencies and deviations.
  
• Ensure corrective and preventive action and change control requirements are efficiently met.
  
• Maintain accurate and detailed documentation of all validation activities including protocols reports master plans engineering specifications (URS DS FS etc.) etc.
  
• Serve as liaison between vendors and contractors coordinating required handoffs.
  
• Identify opportunities for process improvements and implement best practices in validation activities.
  
• Provide ongoing support and technical expertise through validation and qualification activities.
  
• Ensure all validation activities comply with FDA EMA GAMP 5 and other relevant regulatory bodies.
  
• Additional responsibilities as required.
  

Requirements

• Bachelors degree in related engineering discipline.
  
• 7 years of commissioning qualification and validation engineering experience with a wide range of equipment and systems experience in the pharmaceutical manufacturing industry.
  
• Proven success in managing reviewing authoring and approving full lifecycle technical validation documentation.
  
• Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members and schedule/develop project plans.
  
• Experienced in vendor coordination/management.
  
• Advanced knowledge of industry regulations and standards. Strong knowledge of riskbased validation approach.
  
• Experienced in paperless validation (Kneat ValGenesis etc.) is a plus.
  
• Strong understanding of industry regulations and requirements.
  
• Strong attention to detail and commitment to quality and compliance.
  
• Excellent problem solving and analytical skills.
  
• Excellent communication and interpersonal 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