Start date: as soon as possible
Duration: 6 months with possibility for extension
Location: Solothurn area, Switzerland
CQV Engineer (m/f)
For one of my Greenfield clients I am currently looking for a "CQV Engineer" with the following requirements:
- Leading/Participating as team member of an integrated area -specific work team with key emphasis on execution and documentation of commissioning tests.
- Supporting the coordination of the integrated CQV Team area team (participants from different departments, vendors, etc.)
- Management and generation of weekly commissioning activity 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 commissioning 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, DeltaV 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 commissioning activities in adherence to site safety procedures.
- 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 commissioning test protocols, reports, project change controls and deviations using KNEAT system.
- Proactively highlighting any issues around compliance.
- Participating in internal and external audits and inspections if required.
Skills set required:
- 7 - 10 years of related industry experience or training or a combination of education, experience and training.
- Knowledge of industry standards and guidelines, such as, AAALAC, ASME BPE, ISPE Baseline Guides, CFR's, OSHA, etc.
- Engineering and project management experience in facility construction and/or retrofits of operating facilities in the Pharmaceutical Industry with some exposure to engineering, construction, commissioning and/or validation of capital projects.
- Previous construction or architectural/engineering firm experience would be advantageous, but not critical as significant on the job training will be given.
- Basic project management skills would be valuable with some experience in the principles of estimating and scheduling; cost controlling and monthly project reporting.
- Experience in GMP project management preferred
- Excellent written and oral communication skills and interpersonal skills to lead diverse cross-functional teams\Experience in IMB/FDA environment advantageous
- Strong technical writing and communication skills
- Ability to pay high level of detail and QA data to very high standard
- Problem solving and Project Management skills. Must be goal-oriented and able to prioritize and manage risks
If you are interested in this position please send your updates CV to: k.blomberg (at) realstaffing.com or contact me under +41 (0) 44 588 2636.
Looking forward to speaking to you.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.