- International Pharma Company in Solothurn
- Start ASAP - 12 Months Contract
About Our Client
For our client, a Biopharmaceutical company based in Solothurn, we are looking for a Project Engineer CQV to start ASAP for a 12 months contract which can be extended.
As a member of the Engineering team, you will be responsible to support the CQV activities for the new facility in Solothurn.
The role is a contract position as part of the CQV team, and you will work in a IWT (Integrated work Team) with people coming from different departments and areas. The main task is to execute the assigned commissioning, qualification and validation tasks according to the schedule to ensure that the area of responsibility will be ready for PPQ.
- Leading/Participating as team member of an itegrated area -specific work team with key emphasis on execution and documentation of Commissioning/Qualification/validation ( CQV)tests.
- Supporting the coordination of the integrtated CQV Team area team (participants from different 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 isues, puunch items and non-conformities etc.
- General execution of CQV and DCS/MES software shake-down activities, including EMs, phases, operations, procedures and recipies.
- Review and update of functional specifications, including EMs, phases, operations, procedures and recipies, DeltaV graphics and other software components.
- Accountable for scheduling, tracking, reporting and achieving project the project milestaones 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.
- Generation and execution of commisisoing test protocols, reports, project change controls and deviations using KNEAT system.
- Proactively highlighting any issues around compliance.
The Successful Applicant
- Minimum educational level necessary to perform the job (High School diploma, Associate's 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)
What's on Offer
Are you looking for a new opportunity within Biopharmceuticals and do you have the above requested experiences? Please apply now