Lonza - Bend _ US - EPCM CQV Process Equipment - remote

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ProPharma Group

Bend, OR
Full Time
9mo ago

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

The scope of work is to help with administration of documentation organization, routing for approvals and tracking of all documentation related to qualification activities for both facilities systems and process equipment systems. It is expected that this would required 40-50 hours per month throughout the duration of the project (anticipated to end May 2022) and could be performed remotely. A Lonza issued laptop will be procured and document management system author training will be provided.

The documents include the following:

  • Commissioning /Qualification Protocol
  • Equipment Folder
  • I&C Instrumentation and Component list for each system
  • ICA Instrument Criticality Assessment for each system
  • Spare parts list
  • Equipment Specification
  • Product contact parts - Materials Of Construction and Surface Area analysis
  • Hazop
  • Summary Report

 

Qualifications

  • Qualified candidates will possess a Bachelor’s degree in related field along with 2 plus years related industry experience.
  • Candidates must have excellent verbal communication and technical writing skills.
  • Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
  • Familiarity with many aspects of validation is expected.
  • Experience with temperature mapping.
  • Proficient in Microsoft Word, Excel, Power Point and Project.
  • Must be willing to travel regionally and/or nationally throughout the US.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***

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