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Environmental Monitoring Performance Qualification Specialist (29995258)

ProQualityNetworkJuncos, PR, US

Hace 20 horas

Descripción del trabajo

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

Bachelors degree in Science, Engineering, or a related technical field

6 to 8 years of hands-on experience in Environmental Monitoring and / or Validation within a GMP-regulated environment

Strong knowledge of cleanroom classifications (ISO / Grade), aseptic technique, contamination control principles, and regulated industry practices

Excellent documentation and technical writing skills with strong attention to detail

Full professional proficiency in English; strong interpersonal and communication skills

Must be available to start the first week of August

Must be available to work during holiday shutdowns and Thanksgiving week to provide onsite coverage as needed

Preferred Qualifications

Experience with Environmental Monitoring Performance Qualification and Smoke Testing (Airflow Visualization Studies AVS)

Familiarity with aseptic manufacturing operations and regulatory inspection readiness

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

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Specialist • Juncos, PR, US