Website Lenox Executive Search
Lenox Executive Search is seeking an experienced Validation Specialist who can write, document and perform execution with minimum training for a Cleaning Validation Lead position. This is a fully onsite, 1-2 Year contractual role with our leading global pharmaceutical client, at their Swiftwater, PA site.
- 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
- 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
- Cleaning or Shipping experience strongly desired.
- 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.
- BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical)
- 4+ total years of experience working in a biologic, vaccine or pharma industry.