Validation Specialist III

Title: Validation Specialist III
Duration: 6 Months+ (Possibility to extend after December)
Location: Swiftwater, PA- Hybrid

MUST HAVE:

• Cleaning validation experience
• Strong communication skills
• Ability to manage, execute and troubleshoot on their own
• Strong Microsoft Suite skills

Description:
Duties
• 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

Basic Qualifications:
• 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

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