Cleaning Validation Specialist - Swiftwater, United States - Rangam

    Rangam
    Rangam Swiftwater, United States

    Found in: Lensa US 4 C2 - 1 week ago

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    Description

    Pay Rate: $70.00 to $75.00 per Hourly

    Location: Swiftwater, PA (Hybrid)

    Job Description:

    Hybrid will usually be 4 days onsite and one remote but manager prefers flexibility

    Manager is looking for stronger CLEANING Validation experience, not Computer Validation.

    Description:

    • THIS IS A CLEANING VALIDATION POSITION.

    Duties

    Experience in cleaning validation in the biologics or vaccine industry to include the following:

    • Experience in authoring, reviewing, executing and approving validation documents.
    • Interface with Quality organization and the ability to defend rationale in validation documents.
    • Ability to develop cleaning cycle and lead the investigation or trouble shooting.
    • Ability to review and analyze data.
    • Cleaning Validation experience
    • Acceptance criteria determination
    • Sampling plans and sample size determination
    • Rinse and Swab sampling experience
    • Bracketing and worse case rating
    • QC testing requirements
    • Dirty hold times and clean hold times

    Basic Qualifications:

    • Experience utilizing Microsoft Word, Excel, and Outlook
    • Experience writing and revising documents (e.g. testing methods, protocols, reports)
    • Experience performing testing in a GMP setting
    • MS Project experience

    Skills

    • Proficiency in utilizing documentation system to author protocols and reports
    • Experience participating in teams and collaborative work environments.
    • Good communication skills (verbal and written), math skills, general computer skills
    • Team environment a must
    • E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process
    • Strong root cause analysis with cGMP experience.

    Education

    • BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 2+ total years of experience working in a biologic, vaccine or pharma industry.
    • Minimum 1-3 years validation experience
    • No degree requirements but bonus if related.

    MUST HAVE:

    • cleaning validation experience
    • strong communication skills
    • ability to manage, execute and troubleshoot on their own
    • Strong Microsoft Suite skills