Validation Engineer

• 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 etc.
• Identify and develop the scope of work required per systems (including loop checks hardware checkouts other related CQV tasks).
  
• Oversee and track the development of user requirements documentation on a systembysystem basis.
• Collaborate with CQV Team instrumentation contractors and process equipment vendors to develop list of systems and system boundaries. Coordinate instrument and equipment checkout activities.
  
• Oversee calibration requirements with instrumentation contractors.
  
• Charged with the handoff of systems between vendors and contractors.
  
• Manage and review vendor contracts (review timesheets earned value project scope changes etc.)
• Support the development of proposal writing for contracting and CQV resources.
  
• Ensure effective and active communication with stakeholders project managers on all project updates progress risks resolutions budget contractor and vendor statuses change requests and so on.
  
• Elevate any potential risks or issues to upper management and determine any potential delays in deliverables.
  
• Ensure all required documentation is recorded in a timely and efficient manner and meets regulatory and quality guidelines.
  
• Lead meetings with project managers and team members as needed.

Requirements

• Bachelors degree in engineering or related technical field.
  
• 5 years of CQV experience in a regulated GMP environment.
  
• Experienced with facility buildout requirements and project planning.
  
• Experience working with equipment and instrumentation contractors and vendors.
  
• Experience supporting proposal writing.
  
• Strong understanding of regulatory requirements (FDA EMA ICH etc.) and industry standards (GMP GLP GAMP etc.) related to CQV.
  
• Excellent project management skills including the ability to develop and manage project plans schedules and budgets.
  
• Exceptional attention to detail and the ability to review technical documentation thoroughly.
  
• Effective communication and interpersonal skills enabling collaboration with diverse crossfunctional teams.
  
• Experience with risk assessment methodologies (e.g. FMEA) and root cause analysis.
  
• Travel is required. 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