Leading/Participating as team member of an integrated area -specific work team with key emphasis on execution and documentation of (CQV)tests. Supporting the coordination of the integrated CQV Team area team. 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. 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.
CQV Engineer (Bulk Drug Substance)
- Technik / Industrie
Within the Pharmaceutical Industry globally & successfully operating company.
A dynamic working environment focusing on career opportunities where multi-cultural teams from all over the world strive the best results. This position is currently until October this year including a strong option to get extended.
Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
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.
Englisch: Very good
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