USA-Validation Specialist III

Industry: Biotechnology
Title: Validation Specialist III
Job ID: SNFIJP00008644
Location: Swiftwater, PA (Hybrid)
Duration: 12 months (+Possibilities of extension)
*THIS IS A CLEANING VALIDATION POSITION.

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

Notes from the Manager:
Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. Prefer new hire to be open to very occasional weekend work or overtime if needed. May also need to switch a shift from morning to afternoon here and there. Start ASAP with possibility to extend after December 2024. Mostly hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in case they are needed onsite the extra day. Minimum 1-3 years validation experience, open to more experience within rate range. No degree requirements but bonus if related. MUST HAVE: 1. cleaning validation experience 2. strong communication skills 3. ability to manage, execute and troubleshoot on their own 4. Strong Microsoft Suite skills

PH_EN

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