Cleaning validation Job at I3 INFOTEK INC, Swiftwater, PA

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  • I3 INFOTEK INC
  • Swiftwater, PA

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

Job Tags

Temporary work, Remote job, Flexible hours, Shift work, Day shift,

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