What are the responsibilities and job description for the Validation Specialist, Cleaning position at Katalyst Healthcares & Life Sciences?
Roles & Responsibilities:
- BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 5 total years of experience working in a biologic, vaccine or pharma industry.
- Experience in authoring, reviewing, executing and approving validation documents.
- Interface with Quality organization and the ability to defend rationale in validation documents.
- Ability to develop cleaning cycle and lead the investigation or trouble shooting.
- Ability to review and analyze data.
- Cleaning Validation experience.
- Acceptance criteria determination.
- Sampling 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.
- 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.
