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Validation Specialist

Allentown-Bethlehem-Easton Metro Area, PA

Posted: 09/12/2019 Job Type: Scientific Job Number: JN -092019-25591

Job Description

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 review and analyze data

Cleaning Validation experience

Acceptance criteria determination

Sampling procedures, 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 4+ total years of experience working in a biologic, vaccine or pharma industry

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