Cleaning validation Job at I3 INFOTEK INC, Swiftwater, PA

SXRRWDZsRFdySmZQWjVCUnVBTHFid2owK2c9PQ==
  • 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

StaffManagement

Scale Operator Job at StaffManagement

 ...Staff Management Group is seeking a Scale Operator for our client in Randolph, NJ. Please read the ENTIRE job description and ALL of the job requirements BEFORE applying for this position. Schedule: ~1st Shift: 7:30AM - 4PM ~ Plus Overtime Pay Rate... 

United Nations Department of Operational Support

Administrative Assistant, New York City Job at United Nations Department of Operational Support

 ...Transportation Section at United Nations Secretariat, within the Facilities and Commercial Activities Service, Division of Administration....  ..., striving to provide effective and efficient planning, management, maintenance and operation for all existing physical facilities... 

Twenty First Services

Insurance Field Inspector Job at Twenty First Services

 ...Insurance Field Inspector Pampa & Surrounding Area We are a regional insurance inspection firm servicing the southeastern United States. We are seeing work in Pampa, and the surrounding areas. Typically, within a 30-mile radius. We are looking to add someone permanent... 

DoorDash

Delivery Driver Job at DoorDash

Why Deliver with DoorDash? DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you'll stay busy with a variety of earnings opportunities and can work when it...

Cytokinetics

Senior Drug Safety Case Manager Job at Cytokinetics

 ...mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. The Senior Drug Safety Case Manager will independently support the Drug Safety Department. The candidate...