Cleaning Validation Specialist

4 weeks ago


New York, United States CareerBuilder 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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