CQV Engineer

Highly Competitive
  1. Contract
  2. Validation
  3. Switzerland
Solothurn, Switzerland
Posting date: 06 May 2021
This vacancy has now expired

An exciting contract position has become available for a CQV Engineer, you will be part of a team supporting CQV activities for a new facility. The focus will be executing assigned commissioning, qualification and validation tasks. This is a 12 month rolling contract with the possibility of an extensions.

Job Responsibilities

  • Leading/Participating as team member of an integrated area -specific work team with key emphasis on execution and documentation of Commissioning/Qualification/validation (CQV)tests.
  • Supporting the coordination of the integrated CQV Team area team (participants from different company departments, vendors, etc.)
  • Management and generation of weekly CQV activities planning and coordination with utility, calibration and automation teams.
  • Mitigation, follow-up, close out and verification of open/closed issues, punch items and non-conformities etc.
  • General execution of CQV and DCS/MES software shake-down activities, including EMs, phases, operations, procedures and recipes.
  • Review and update of functional specifications, including EMs, phases, operations, procedures and recipes, Delta V graphics and other software components.
  • Accountable for scheduling, tracking, reporting and achieving project the project milestones according to the schedule.
  • Providing inputs into the core aspects of operations, CQV planning & execution.
  • Planning and execution of all CQV activities in adherence to site safety procedures.
  • Operate in a manner consistent with the site incident and injury free philosophy.
  • Understanding and applying industry specific compliance standards/regulations to all CQV activities.
  • Leading of risk assessments, root cause analysis, investigations and facilitate/support implementation of corrective and preventive actions.

Skills and Requirements

  • Minimum educational level necessary to perform the job (High School diploma, associate degree, Bachelor's Degree, Masters, PhD)
  • Technical diploma or Degree in Engineering/Life Sciences or greater preferred
  • Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 7 - 10 years)

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.