Environmental Monitoring Performance Qualification Specialist (29995258)

Job Description

Job Description

Job Title : Environmental Monitoring Performance Qualification (EM PQ) Specialist

Location : Juncos, PR

Employment Type : Contract (via ProQuality Network)

Join our team as an EM PQ Specialist , supporting the execution of Environmental Monitoring (EM) Performance Qualification protocols within a highly regulated biotechnology manufacturing environment. In this role, you will ensure compliance with Good Manufacturing Practices (GMP), assist in cleanroom qualification efforts, and collaborate with Quality, Validation, and Engineering teams to support site readiness and operational excellence.

Key Responsibilities

• Execute Environmental Monitoring Performance Qualification (PQ) activities, including viable / non-viable air sampling, surface monitoring, and personnel monitoring
• Support cleanroom qualification and validation processes aligned with regulatory expectations
• Prepare, execute, and review GMP documentation, including protocols, data packages, and reports
• Ensure compliance with cGMPs, site SOPs, and applicable regulatory requirements
• Perform smoke testing (Airflow Visualization Studies AVS) as required to support EM qualification
• Collaborate cross-functionally with Quality Assurance, Validation, and Engineering groups to support project timelines
• Assist in additional tasks as needed to meet departmental objectives and compliance standards

Requirements

Preferred Qualifications

Interested candidates are encouraged to apply via the job description link and submit an updated resume for consideration.