Job Description

Title: Cleaning Validation Engineer

Location: Swiftwater, PA

Duration: Long-term contract

Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. Manager flexible. 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 . Hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in case they are needed onsite the extra day.

MUST HAVE:

• BS/MS degree
• 2+ years strong experience in cleaning validation in the Pharma biologics or vaccine industry
• Experience in authoring, reviewing, executing and approving validation documents. (e.g. testing methods, protocols, reports)
• Ability to develop cleaning cycle and lead the investigation or trouble shooting.
• Strong root cause analysis with cGMP experience.
• Ability to review and analyze data.
• Cleaning Validation experience such as:
• 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
• EXCELLENT communication skills
• Ability to manage, execute and troubleshoot on their own
• Strong Microsoft Suite skills (Word, Excel, Project, Outlook)
• Strong Microsoft Suite skill
• Experience participating in teams and collaborative work environments.
• E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process

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