Title: Environmental Monitoring Performance Qualification Specialist
Location: Central Florida, U.S.
Work Model: 100% Onsite – Local Candidates Only
Positions: 1
Overview
Our client is seeking an Environmental Monitoring Performance Qualification Specialist with a strong technical foundation in process validation, automated system integration, environmental monitoring, and aseptic process qualification. The ideal candidate will support cleanroom performance, controlled environmental systems, equipment qualification activities, and environmental monitoring programs to ensure operational readiness and compliance with regulatory standards.
This role requires hands-on experience in GMP environments and the ability to apply engineering, scientific, and statistical principles to validate environmental controls and process performance across manufacturing operations.
Key Responsibilities
Environmental Monitoring & Aseptic Qualification
- Execute routine and non-routine environmental monitoring activities, including viable and non-viable particle monitoring, surface sampling, and cleanroom assessments.
- Support aseptic process qualifications (APQ), including media fills and contamination control initiatives.
- Perform cleanroom validation tasks such as airflow visualization, HEPA filter integrity testing, pressure differentials, and room recovery evaluations.
- Ensure compliance with regulatory expectations related to environmental control, including ISO, EU Annex 1, and FDA guidance.
Process & Equipment Validation
- Conduct performance qualification (PQ), operational qualification (OQ), and installation qualification (IQ) activities for cleanrooms, controlled environments, and manufacturing systems.
- Validate equipment and automated platforms including bioreactors, laminar flow hoods, cold rooms, inspection systems, HVAC systems, Kaye Validator, and automated assembly systems.
- Support validation efforts for CNC machining, injection molding, and packaging processes as required.
Automated Systems & Integration
- Work with MES/SCADA platforms to monitor and troubleshoot automated environmental and process control systems.
- Ensure integration and data accuracy across automated inspection systems, Assembly Automation (AA), and manufacturing equipment.
- Collaborate with automation engineers to ensure alignment between system functionality, environmental controls, and validation requirements.
Quality Systems & Compliance
- Develop and execute validation protocols (IQ/OQ/PQ), reports, and technical documentation.
- Support deviations, CAPA investigations, change controls, and associated records.
- Maintain strong documentation practices aligned with GMP, GDP, and data integrity guidelines (ALCOA+).
- Participate in internal and external audits, providing environmental and validation documentation support.
Statistical & Analytical Support
- Apply statistical methods for process capability assessments, trend analysis, environmental monitoring program performance, and validation verification.
- Interpret EM data to identify patterns, excursions, and areas requiring corrective action or improvement.
Cross-Functional Collaboration
- Partner with Manufacturing, Quality Assurance, Validation, Engineering, and Facilities teams to ensure environmental control readiness and ongoing compliance.
- Provide technical support and subject matter expertise related to cleanroom performance, aseptic operations, and environmental monitoring strategies.
Required Qualifications
- Bachelor’s degree in Microbiology, Engineering, Biotechnology, Life Sciences, or a related field.
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8+ years of experience in environmental monitoring, aseptic operations, validation, or contamination control within a regulated GMP environment.
- Hands-on experience with cleanroom validation, aseptic processing, HVAC systems, and controlled environments.
- Strong understanding of GMP, ISO cleanroom classifications, aseptic operations, and contamination control principles.
- Proficiency with automated systems such as MES, SCADA, inspection platforms, and environmental monitoring systems.
- Experience drafting and executing validation protocols, technical reports, and controlled documentation.
- Strong analytical, organizational, and technical writing skills.
Preferred Qualifications
- Experience supporting client-facing or CDMO operations.
- Familiarity with Kaye Validator systems, automated visual inspection systems, and automated assembly lines.
- Experience with statistical tools for trending and validation analysis (e.g., Minitab).
- CAPA and deviation investigation experience.
- Working knowledge of bioreactor systems, CNC or injection molding equipment, and packaging processes.
