Facility & Equipment Validation Specialist

About The Opportunity

Planet Pharma is partnering with a 503B outsourcing facility in Albany, NY to place a Facility & Equipment Validation Specialist. This is a contract-to-hire role for a technically strong validation professional with direct experience in aseptic pharmaceutical manufacturing environments. The successful candidate will play a hands-on role in extracting, reviewing, and rebuilding validation documentation as the facility transitions from third-party managed validation to an internally owned, compliant program. HVAC qualification experience is a firm requirement for this role.

What You'll Be Doing

• Facility & Equipment Qualification
  • Plan, execute, and document IQ/OQ/PQ for new and existing equipment including cleanroom HVAC systems, isolators, Bio-Safety Cabinets, Laminar Flow Hoods, filling equipment, and environmental monitoring systems
  • HVAC qualification is a core requirement of this role — experience with cleanroom HVAC systems, differential pressure, and airflow qualification is essential
  • Support cleanroom qualification activities including ISO classification, airflow visualization studies, and recovery testing
  • Validate and maintain state of facility utilities including compressed air, clean steam, WFI, HVAC, and differential pressure systems
• Validation Program Development
  • Extract, review, and critically evaluate existing third-party validation documentation
  • Build and own new internal validation documents, protocols, and reports from the ground up in alignment with FDA 503B and cGMP requirements
  • Maintain and update Validation Master Plans (VMP), equipment qualification files, and lifecycle documentation
  • Ensure all validation activities meet data integrity requirements per ALCOA+ principles
• Aseptic Processing & Sterility Assurance Support
  • Support media fills, smoke studies, and contamination control strategy implementation
  • Participate in investigations related to equipment failures, environmental excursions, or sterility assurance risks
  • Collaborate with Quality, Operations, and Facilities to ensure equipment and cleanroom conditions support aseptic processing
• Calibration, Change Control & Inspection Readiness
  • Oversee calibration and preventive maintenance schedules for critical equipment — reviewing and approving certificates, PM records, and service reports
  • Evaluate equipment or facility changes for validation impact and perform risk assessments (FMEA, hazard analysis) to support change control decisions
  • Maintain validation documentation in an audit-ready state at all times
  • Support internal audits and FDA inspections by presenting validation evidence and responding to technical questions

What We're Looking For

• Bachelor's degree in Engineering, Life Sciences, or related technical field
• 3–5 years of experience in aseptic pharmaceutical manufacturing, preferably in a 503B outsourcing facility or sterile injectable environment
• Hands-on HVAC qualification experience is required — candidates without this will not be considered
• Strong knowledge of cGMP, USP //, and FDA 503B guidance
• Direct experience with equipment qualification (IQ/OQ/PQ) and cleanroom validation
• Familiarity with calibration systems, preventive maintenance programs, and equipment lifecycle management
• Excellent technical writing skills and ability to produce clear, compliant validation documentation
• Strong problem-solving skills with a proactive, ownership-oriented mindset

Conversion Opportunity

This engagement begins as a 3-month contract with the opportunity for permanent conversion based on performance and mutual fit. Permanent compensation will be discussed directly between the candidate and the client at the time of conversion.