Back to Job Search

Senior CQV Engineer

  • Location: Switzerland
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 17 days ago

Senior CQV Engineer

RESPONSIBILITIES:

· Become familiar with the user, functional, installation, operation, and performance requirements for assigned projects and tasks.

· Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in the development of equipment commissioning and validation documents

· Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.

· Support Validation Master Plan development

· Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.)

·Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.

·Support Validation Summary Report development

·Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).

· Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.

· Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).

· Support resolution of engineering/validation issues found during equipment validation.

· Attending meetings as required to support equipment installation and operation

· Providing quality oversight and approval for validation documents as needed. (Function test, IQs, OQs, etc…)

·Support developing SOP's

·Other tasks as requested or required by Client to support Equipment Validation for each project.

QUALIFICATION AND REQUIREMENTS

· 5-8 Years of Equipment Validation experience working within a cGMP & FDA Regulated environment, must have WFI experience

·Previous experience with CQV activities for equipment outlined above.

· Supporting engineer will be resident at the Client facility or a previously agreed upon location (i.e. vendor's location).

· A strong understanding and knowledge of equipment and automated systems is desired.

· Support to be performed as required by the project schedules- Shift work required for 24x7 coverage and/or extended and weekend hours are expected for periods of time.

· Previous Experience working in a cGMP and FDA regulated environment

If you are interested in finding out more please forward your details to peterjefferys@hydrogengroup.com

If you know anyone who may be interested I am offering £500 referral fee for any successful candidate

...