The Fountain Group is Hiring an USA-Validation Specialist III (Engineering) Near Swiftwater, PA
Duties________________________________________1. Experience in cleaning validation in the biologics or vaccine industry to include the following:1. Experience in authoring, reviewing, executing and approving validation documents2. Interface with Quality organization and the ability to defend rationale in validation documents3. Ability to review and analyze data2. Cleaning Validation experience1. Acceptance criteria determination2. Sampling procedures, plans and sample size determination3. Rinse and Swab sampling experience4. Bracketing and worse case rating5. QC testing requirements6. Dirty hold times and clean hold timesBasic Qualifications:Experience utilizing Microsoft Word, Excel, and OutlookExperience writing and revising documents (e.g. testing methods, protocols, reports)Experience performing testing in a GMP settingMS Project experienceSkillsProficiency in utilizing documentation system to author protocols and reportsExperience participating in teams and collaborative work environments.Good communication skills (verbal and written), math skills, general computer skillsTeam environment a mustE Doc/GEODE experience with a working knowledge of templates, workflows and approval processStrong root cause analysis with cGMP experience.