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