Cleaning validation Job at I3 INFOTEK INC, Swiftwater, PA

dVFMY0tBRVBxWFRRSVphRGNINE4vQUtPQ1E9PQ==
  • 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

Helix Scribe Solutions

Medical Scribe - Orthopedics (Hand Surgery) Job at Helix Scribe Solutions

 ...work independently with providers we service. Learn more here . We are searching for qualified individuals to service orthopedic hand surgery offices of Lovell Hand & Orthopedic Center in the greater Grand Rapids region of Michigan. You must be able to work shifts... 

PTR Global

Shipboard Operations Field Technician Job at PTR Global

 ...skilled and experienced Field Technician to join our onsite shipboard operations team. The ideal candidate will be responsible for installation of cellular equipment and DAS equipment to provide service to cruise ships throughout the world. This will include but not be... 

Navis Consulting

Assistant Maitre D - Cruise Job at Navis Consulting

Position Title: Assistant Matre d Department: Food & Beverage Restaurant Operations Reports To: Matre d Direct Reports: Assigned Restaurant Personnel Position Summary Supports the Restaurant Manager by supervising restaurant staff and ensuring...

Phaidon International

Senior Learning and Development Consultant Job at Phaidon International

 ... Competitive salary and bonus eligibility 20 Days PTO, 11 National Holidays, Day on your Birthday Attend office holiday parties, annual sales meetings, and incentive-based celebrations off-site Remote Work Flexibility 401(k) with company matching... 

KCD

Sr. Experiential Designer Job at KCD

 ...Position Overview: The Sr. Experiential Designer will play a key role in leading experiential design projects, ensuring excellence in conceptualization, execution, and implementation. This individual will oversee and contribute to multiple concurrent projects, collaborating...