Cleaning Validation Engineer

Hyde Engineering + Consulting - Pennsylvania

Posted 559 days ago
  • Experience
    Mid-Senior level
  • Job function
    Consulting, Engineering, Quality Assurance
  • Employment type
    Full-time
  • Industry
    Biotechnology, Pharmaceuticals
  • Job ID
    4415629

This is a preview of the Cleaning Validation Engineer job at Hyde Engineering + Consulting. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

Are you looking for a meaningful career that makes a difference in the world? Then consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers are able to effectively and safely produce their life enhancing and often life saving medicines.

 

At Hyde E+C we want to attract the industry’s best and brightest to help us achieve our vision to be the premier Biopharma Process Engineering, Validation and Regulatory Compliance Solution Provider in all Markets we service. To do so, we offer competitive compensation, excellent benefits and a strong commitment to work/life balance. At Hyde E+ C you will find these values reflected in our company:

  • Family Happiness
  • Integrity
  • Friendship
  • Wisdom
  • Adventure

General Purpose / Summary

The Cleaning Validation Engineer is a professional who understands cleaning in place processes and can write and execute cleaning validation protocols. The Cleaning Validation Engineer must be a self starter, task oriented, like projects, maintain strong work ethic, offer more than is asked for, and have the potential to see the big picture.  The roles are for positions throughout Pensylvania.

 

Skills and Knowledge

  • Provides expertise in cleaning processes on a wide variety of sanitary equipment, including vessels, centrifuges, autoclaves, fermentors, UF and chromatography units
  • Writes protocols for cleaning validation, including equipment dirty and clean hold times
  • Execution, Authoring and Review of the above protocols
  • Writes deviations, CAPAs and change controls
  • Assists the manufacturing operation in problem solving with regards to cleaning of equipment and systems
  • Swab and rinse sampling experience
  • Experience with tanks and spray ball / spray coverage testing
  • Ability to plan and manage own work
  • Manages client relationships in complex environments
  • Promotes cGMP compliance within the workplace by following site cGMP procedures
  • Incorporate cGMP and regulatory compliance into assigned projects scope, design & construction work
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

 

 

Desired Skills and Experience

Qualifications

  • B.Sc or B.Eng. degree in Engineering  or Life Sciences
  • Minimum 4 years in equipment, process or clean utility systems validation experience is required.
  • Must comply with cGMP requirements (gowning, documentation, procedures) and have the ability to generate and gain approval of validation documentation.
  • Must possess a good understanding of clean room or classified area requirements.
  • Individual will be expected to use creativity and innovation to address urgent and/or complex problems and propose solutions and have the ability to work autonomously on assignments and projects.
  • Strong verbal and written communication skills; excellent organizational and time utilization skills.
  • Strong computer knowledge including Microsoft Office products
  • Proficient knowledge of biopharmaceutical manufacturing, design is required.
  • Proficient knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially related to sanitary and sterile operations, is essential.
  • Environmental compliance experience
  • Relate to people at all levels of the organization, including diverse cultures
  • Must be willing to work off-shift and weekends, if necessary
  • A strong willingness to travel

About this company

Hyde Engineering + Consulting

Since 1993, Hyde Engineering + Consulting has worked as an integral part of project teams for clients and equipment vendors resulting in the successful construction, commissioning and validation of facilities and equipment . At Hyde Engineering + Consulting we provide high value engineering, compliance, qualification and automation solutions to the Biopharmaceutical and Biocommodity industries. Our knowledge and experience of the industry, as well as our in-depth understanding of the regulatory FDA/EMEA risk based management approach, provides added value for our clients both within the US and globally. Our offices are located: Domestically - California, Colorado, North Carolina, Pennsylvania, and Massachusetts; Internationally - Ireland, India, Singapore

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