Cleaning Validation Specialist

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Swiftwater, United States eTeam Full time

Must Have: 1. cleaning validation experience 2. strong communication skills 3. ability to manage, execute and troubleshoot on their own 4. Strong Microsoft Suite skills

Roles and Responsibilities

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

o Experience in authoring, reviewing, executing and approving validation documents.

o Interface with Quality organization and the ability to defend rationale in validation documents.

o Ability to develop cleaning cycle and lead the investigation or trouble shooting.

o Ability to review and analyze data.

• Cleaning Validation experience

o Acceptance criteria determination

o Sampling plans and sample size determination

o Rinse and Swab sampling experience

o Bracketing and worse case rating

o QC testing requirements

o Dirty hold times and clean hold times

• Experience writing and revising documents (e.g. testing methods, protocols, reports)

• Experience performing testing in a GMP setting


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

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