Job Details
Posted 21 July, 2026
Job Id: 629442
Facility & Equipment Validation Specialist
Job Description
Facility & Equipment Validation Specialist
- Contract-to-Hire | Albany, NY (100% On-site) | Mid-August 2026 Start
- Engagement Type: 3-Month Contract with permanent conversion opportunity
- Location: Albany, NY — 100% On-site
- Start Date: Mid-August 2026
- Pay Rate: $55 – $70/hr (W2) | Based on experience
- Experience Level: 3-5 Years
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
- 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
- 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
- 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
- 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 <797>/<800>/<825>, 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
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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
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