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Ellab

55 jobs near Columbus, OH

Ellab Inc

Certification Tech

Cambridge, MA

Certification Tech: * 3-5 years of experience performing certification, calibration, or field service activities in pharmaceutical, biotechnology, laboratory, or other regulated environments.

New

LanceSoft

QA Validation Specialist 3

Portsmouth, NH · On-site

Experience with Ellab for Temp Mapping is a plus Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media ...

ImmunityBio, Inc.

Validation Engineer III

Dunkirk, NY · On-site

Experience with ELLAB data loggers and systems * Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment * Good ...

LanceSoft

QA Validation Specialist 3

Portsmouth, NH · On-site

Experience with Ellab for Temp Mapping is a plus Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media ...

Lancesoft

QA Validation Specialist 3

Portsmouth, NH

Experience with Ellab for Temp Mapping is a plus Manager is looking for candidates with Cleaning Val (CIP, COP, SIP). 95% of equipment is Single Use, so the Cleaning Val is limited mostly to Media ...

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1076 GMP Validation Specialist - Equipment and Cleaning

Harvest Technical Services, Inc.

Portsmouth, NH • On-site

$70 - $79.58/hr

Contractor

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

Onsite: Portsmouth, New Hampshire


  • Experience with Kneat is required. Building equipment requalification in Kneat.
  • Experience with Ellab for Temp Mapping is a plus
  • Cleaning Validation experience (CIP, COP, SIP).
  • Equipment includes Autoclaves, Parts Washers, and Storage equipment (cold and ambient).


JOB DESCRIPTION

  • Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment. 
  • Drive/own the validation plans and execution of equipment changes and process improvements.
  • Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
  • Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.
  • Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.
  • Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Clean-In-Place (CIP), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
  • Develop validation protocols from plans and engineering documents.
  • Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc.
  • Perform assigned Quality Systems activities within Document Management System (DMS), TrackWise Quality System (Change Control, Deviation, CAPA).
  • Perform other duties as assigned.
  • Equipment data management. 
  • Sustainability and energy improvement initiatives.  

The hiring rate for this position is $70 to $79.58/per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.


Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.


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