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USA-Validation Specialist III (Engineering)

  • Permanent
  • Anywhere

Website TalentBurst, Inc.

TalentBurst, Inc.

Company : TalentBurst, Inc.

Country: United States

Location : Swiftwater, Pennsylvania

Post: Sun, 02 Oct 2022 03:28:16 GMT

Expires: Sun, 30 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Position: Validation Specialist

Location: Swiftwater, PA

Duration: 5 months

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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