Validation Specialist - Swiftwater, United States - Intone Networks

Intone Networks
Intone Networks
Verified Company
Swiftwater, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Position:
Cleaning Validation Specialist

Location:
Swiftwater, PA

Duration:
Long term Contract

  • Experience in cleaning validation in the biologics or vaccine industry to include the following:
  • Experience in authoring, reviewing, executing and approving validation documents.
  • Interface with Quality organization and the ability to defend rationale in validation documents.
  • Ability to develop cleaning cycle and lead the investigation or trouble shooting.
  • Ability to review and analyze data.
  • Cleaning Validation experience
  • Acceptance criteria determination
  • Sampling plans and sample size determination
  • Rinse and Swab sampling experience
  • Bracketing and worse case rating
  • QC testing requirements
  • 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)
  • BS/MS degree
  • 2+ total years of experience working in a biologic, vaccine or pharma industry
  • Experience writing and revising documents (e.g. testing methods, protocols, reports)
  • Experience performing testing in a GMP setting
  • Proficiency in utilizing documentation system to author protocols and reports
  • Experience participating in teams and collaborative work environments.
  • 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.
  • Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. Manager flexible. Must be open to very occasional weekend work or overtime if needed. May also need to switch a shift from morning to afternoon on occasion.
  • Start ASAP with possibility to extend after December 202
  • 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.

Job Type:
Contract


Pay:
Up to $40.00 per hour


Schedule:

  • 8 hour shift

Work setting:

  • Inperson

Application Question(s):

  • Do you have experience with these: E Doc/GEODE+ experience

Experience:

Cleaning Validation: 5 years (required)

  • Quality control: 5 years (required)
  • GMP: 5 years (required)

Work Location:
In person
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