Validation Specialist
📋 Role Overview & Responsibilities
Looking only for W2 people
Key Qualifications:Proficiency in cleaning validation within the biologics or vaccine industry, including authoring, reviewing, executing, and approving validation documents.Ability to effectively collaborate with the Quality organization and articulate validation rationale.Demonstrated capability in developing cleaning cycles and leading investigative efforts.Strong analytical skills for reviewing and interpreting data related to cleaning validation.Experience in setting acceptance criteria, establishing sampling plans, conducting rinse and swab sampling, applying bracketing and worst-case rating methods, and managing QC testing requirements, including evaluating dirty and clean hold times.Excellent verbal and written communication skills, coupled with the ability to work independently.Proficient in Microsoft Suite applications (Word, Excel, Project, Outlook).Requirements:Bachelor's or Master's degree.Minimum of 2 years' experience in the biologics, vaccine, or pharmaceutical industry.Track record of document writing and revision, along with GMP testing experience.Competency in utilizing documentation systems for protocol and report creation.Team player with experience in collaborative work environments.Familiarity with E Doc/GEODE+ systems, including templates, workflows, and approval processes.Strong understanding of root cause analysis and cGMP principles.
Proficiency in cleaning validation within the biologics or vaccine industry, including authoring, reviewing, executing, and approving validation documents.Ability to effectively collaborate with the Quality organization and articulate validation rationale.Demonstrated capability in developing cleaning cycles and leading investigative efforts.Strong analytical skills for reviewing and interpreting data related to cleaning validation.Experience in setting acceptance criteria, establishing sampling plans, conducting rinse and swab sampling, applying bracketing and worst-case rating methods, and managing QC testing requirements, including evaluating dirty and clean hold times.Excellent verbal and written communication skills, coupled with the ability to work independently.Proficient in Microsoft Suite applications (Word, Excel, Project, Outlook).Requirements:Bachelor's or Master's degree.Minimum of 2 years' experience in the biologics, vaccine, or pharmaceutical industry.Track record of document writing and revision, along with GMP testing experience.Competency in utilizing documentation systems for protocol and report creation.Team player with experience in collaborative work environments.Familiarity with E Doc/GEODE+ systems, including templates, workflows, and approval processes.Strong understanding of root cause analysis and cGMP principles.
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This position is located in Swiftwater, PA with potential relocation and sponsorship assistance depending on candidate qualifications.
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