What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Responsibilities
- Must have 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.
- BS/MS degree.
- 2 total years of experience working in a biologic, vaccine or pharma industry.
- Experience writing and revising documents (e.g. testing methods, protocols, reports).
- Experience performing testing in a GMP setting.
- Proficiency in utilizing documentation system to author protocols and reports.
- Experience participating in teams and collaborative work environments.
- 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.
- Excellent communication skills.
- Ability to manage, execute and troubleshoot on their own.
- Strong Microsoft Suite skills (Word, Excel, Project, Outlook).
