Be among the first 25 applicants
Direct message the job poster from Real Staffing
Responsibilities
* Initiate and manage deviations related to production events within quality systems.
* Evaluate impacts on equipment, products, and materials with support from Subject Matter Experts (SMEs).
* Conduct investigations using root cause analysis tools (e.g., DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix).
* Lead multi-disciplinary investigation teams and workshops.
* Conduct interviews for deviations involving human factors.
* Compile data and write investigation summary reports.
* Define corrective and preventive actions (CAPA).
* Monitor CAPA efficacy and ensure follow-up until closure.
* Provide technical expertise on manufacturing processes.
* Manage deviations to ensure timely completion.
* Propose technical and organizational solutions.
* Report accurately to follow-up platforms.
* Communicate findings/issues to management and other sites.
* Act as SME during internal and external audits.
* Identify and propose improvement opportunities.
* Lead or participate in manufacturing process improvement initiatives.
Requirements
* Bachelor's/Master's degree in Engineering.
* 3-5 years of experience in biotech/pharmaceutical manufacturing (Process Operations or Quality).
* Technical knowledge of biotechnological processes (USP and/or DSP).
* Knowledge of Quality/Compliance requirements within cGMP manufacturing.
* Proficiency in French and English (written and oral).
* Experience with computerized/automated/QMS systems (e.g., Trackwise, ERP, Veeva Vault).
* Proficiency in MS Office Suite (Word, Excel, PowerPoint, Visio).
* Experience with MiniTab or other statistics software is a plus.
* Lean/Six Sigma Certification(s) highly desirable.
* May be required to manage deviations and provide technical expertise beyond their own field to support other Manufacturing Engineers.
Are you ready to shape the future? Then apply now for the position of Manufacturing Engineer (m/w/x) 100%. Feel free to contact Khem Fischlewitz via email at k.fischlewitz(at)realstaffing.com.
We look forward to meeting you! All applicants must possess a Swiss work permit or a Swiss or EU passport.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Seniority level
Not Applicable
Employment type
Contract
Job function
Manufacturing
#J-18808-Ljbffr