Talent.com
Esta oferta de trabajo no está disponible en tu país.
Environmental Monitoring Performance Qualification Specialist (29995258)

Environmental Monitoring Performance Qualification Specialist (29995258)

ProQualityNetworkJuncos, PR, US
Hace 12 horas
Descripción del trabajo

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

  • 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.

    Crear una alerta de empleo para esta búsqueda

    Specialist • Juncos, PR, US

    Ofertas relacionadas
    LC01-042525 Environmental Monitoring Performance Qualification (EMPQ) Scientist

    LC01-042525 Environmental Monitoring Performance Qualification (EMPQ) Scientist

    Validation & Engineering Group, IncJuncos, 077
    Validation & Engineering Group, Inc.V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the followin...Mostrar másÚltima actualización: hace más de 30 días
    LC01-042525 Environmental Monitoring Performance Qualification (EMPQ) Scientist

    LC01-042525 Environmental Monitoring Performance Qualification (EMPQ) Scientist

    Validation & Engineering Group00777, PR, US
    Validation & Engineering Group, Inc.V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the ...Mostrar másÚltima actualización: hace más de 30 días
    Jr. Commissioning & Qualification Specialist

    Jr. Commissioning & Qualification Specialist

    Mentor Technical GroupJuncos, PR
    Quick Apply
    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...Mostrar másÚltima actualización: hace más de 30 días
    Business Performance Sr Manager

    Business Performance Sr Manager

    QRC Group, LLCJuncos, PR, pr
    Business Performancce Sr Manager with experience in regulated industry.OPEX Leader, Financial Acumen, Strategic Planning. Continuous Improvement framework.Managing GxP Documentation, incumbent may b...Mostrar másÚltima actualización: hace 6 días
    EHS Lead

    EHS Lead

    Flexible & Integrated Technical Services, LLCJuncos, PR, PR
    Quick Apply
    For Health and Safety services WHAT MAKES YOU A FIT : The Technical Part : Bachelor’s Degree and or an equivalent of ten (10) years plus of EHS experience within the regulated industry.Bi...Mostrar másÚltima actualización: hace 26 días
    Specialist QA

    Specialist QA

    BioPharma Consulting JAD GroupJuncos, PR, US
    We are seeking a highly motivated.Quality Assurance (QA) Specialist.This individual will be responsible for reviewing and approving key documentation, ensuring compliance, leading investigations, a...Mostrar másÚltima actualización: hace 8 días
    Business Performance Sr Manager

    Business Performance Sr Manager

    QRC Group, IncJuncos, Juncos, Puerto Rico
    Business Performancce Sr Manager with experience in regulated industry.Continuous Improvement OPEX Leader, Financial Acumen, Strategic Planning. Budget management, automation of business perfor...Mostrar másÚltima actualización: hace 5 días
    Business Performance Manager- Juncos - 34416

    Business Performance Manager- Juncos - 34416

    Integrated Services For Productivity & Validation, IncJuncos, PR, pr
    Continuous Improvement OPEX Leader, Financial Acumen, Strategic Planning.This role will be supporting budget management, automation of business performance activities and developing a Continuous Im...Mostrar másÚltima actualización: hace 6 días
    T Mobile Authorized Retailer Sales Associate

    T Mobile Authorized Retailer Sales Associate

    GP MobileJuncos, PR, US
    Retail Sales Representatives (RSR) work as a member of a Retail Team of Experts to bring the T-Mobile brand to life.They’re brand ambassadors who build energy and excitement around our products and...Mostrar másÚltima actualización: hace más de 30 días
    Specialist QA

    Specialist QA

    WEIL GROUP, INC.Juncos, PR, Puerto Rico
    Description : Perform one or more of the following duties and responsibilities in support of site Quality Assurance program under minimal supervision. Review and approve product MPs.Approve process va...Mostrar másÚltima actualización: hace más de 30 días
    Mentor Technical Group is hiring : Technical Writing Specialist in Juncos

    Mentor Technical Group is hiring : Technical Writing Specialist in Juncos

    MediabistroJuncos, PR, United States
    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...Mostrar másÚltima actualización: hace 6 días
    JT383 - SPECIALIST QA

    JT383 - SPECIALIST QA

    Quality Consulting GroupJuncos, PR
    Quick Apply
    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.In...Mostrar másÚltima actualización: hace 5 días
    Business Performance Sr Mgr 34416

    Business Performance Sr Mgr 34416

    InteldotJuncos, Puerto Rico
    Puerto Rico, the United Sates, Europe and Japan.This is a great opportunity for one of our leading clients in.We are seeking a Business Performance Senior Manager to lead strategic planning and con...Mostrar másÚltima actualización: hace 5 días
    Specialist QC

    Specialist QC

    Kelly Services, Inc.Juncos, Puerto Rico, US
    Science, we’re passionate about helping you find a job that works for you.Biotechnology Industry client at Juncos, PR.PHD or MS degree and 2 years of directly related experience OR BS degree and 4 ...Mostrar másÚltima actualización: hace 27 días
    Technical Writer Specialist Job at MENTOR Technical Group Corporation in Juncos

    Technical Writer Specialist Job at MENTOR Technical Group Corporation in Juncos

    MENTOR Technical Group CorporationJuncos, PR, United States
    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...Mostrar másÚltima actualización: hace 2 días
    Specialist QA - 34383

    Specialist QA - 34383

    Mirus Consulting GroupJuncos, PR, Puerto Rico
    Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organ...Mostrar másÚltima actualización: hace 5 días
    Business Performance Sr Mgr

    Business Performance Sr Mgr

    Weil Group, IncJuncos, PR, Puerto Rico
    Manager will partner with QOS&S Leaders to deploy our strategic approach and business performance programs.Design and facilitate a business performance process in alignment with QOS&S Strategic vis...Mostrar másÚltima actualización: hace 6 días
    Specialist Manufacturing

    Specialist Manufacturing

    CencoraJuncos, Puerto Rico
    Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...Mostrar másÚltima actualización: hace 17 días