Cleaning validation Job at I3 INFOTEK INC, Swiftwater, PA

MERVMFNZaHN1cVE2U3hsanBFSk8vR3Z4VXc9PQ==
  • 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

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

Similar Jobs

Michaels Stores

Retail Assistant Store Manager Job at Michaels Stores

 ...prioritize the wellbeing of our teams by providing robust benefits for both full-time and part-time Team Members. Our benefits include health insurance (medical, dental, and vision), paid time off, tuition assistance, generous employee discounts, and much more. For more... 

UHS

Information Security Analyst - Application Security (Penetration Tester) Job at UHS

 ...dynamic and talented Information Security Analyst I-Application Security....  .... Works with staff at all levels in the organization, vendors...  ...Verification Standard) Relevant Entry-Level Certifications (one or...  ...Working knowledge of common cyber security frameworks such as... 

Willson International Limited

Post Entry Specialist Job at Willson International Limited

 ...Looking for a career, at a company where you love to work, all while working from the comfort of home? Do Regulatory changes intrigue you, and the fine details excite you? Want a role that keeps you on your toes? If you answer yes to any of these questions, then... 

Accurate-Airtight Exteriors

Energy Auditor Job at Accurate-Airtight Exteriors

 ...would love to welcome you to our team! We are seeking a trustworthy, enthusiastic, goal-oriented Energy Auditor to be part of our audit and sales team serving our clients in Madison, WI, and the surrounding areas. Accurate-Airtight Exteriors is an energy efficiency... 

Russell Tobin

Technical Designer Job at Russell Tobin

 ...with potential extension Pay rate: $38.00-40.00/hr on w2 Note: Please include details on the specific product types you have worked on not just the name of the brand. Also, include an example of detailed fit comments & tech pack. Job Summary: Individual...