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Microbiology Technical Writer

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Biotech

2021-12-03 07:32:25

Job location Irvine, California, United States

Job type: fulltime

Job industry: Science & Technology

Job description

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.

We focus on providing quality consulting services to ensure our client u2019s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer u2019s expectations.

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We are looking for a senior-level Validation Engineer to join our team. This is an on-site position. The ideal candidate should have background in Microbiology Quality Control.

Responsibilities

  • Prepare, review, revise, and maintain technical documents
  • Conduct investigations, report findings, and remediate root causes of environmental excursions
  • Draft and execute validation protocols and reports
  • Revise Standard Operating Procedures
  • Maintain standardized language and documentation practices that allow for consistent execution of documents.


Requirements
  • 6-10 years of Validation, Technical Writing, and Investigations with QC Microbiology background
  • Must have significant experience working with aseptic production areas
  • Demonstrated experience with Standard Operating Procedures and Investigations
  • Demonstrated experience with environmental monitoring and/or qualifying classified areas.
  • Experience in a biotech/pharmaceutical laboratory and/or manufacturing environment.
  • Strong knowledge of cGMPs
  • Strong attention to detail
  • Excellent written and verbal communication skills

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