| Location | Glattpark-Opfikon,, Switzerland |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 24260 |
| Published | 1 day ago |
In partnership with our biopharmaceutical client in Neuchâtel, we are searching for a Manufacturing Engineer. The primary responsibility is to support manufacturing operations in achieving their quality and productivity goals.
The role specifically focuses on providing technical expertise for investigating manufacturing process deviations and fostering continuous improvement. Key areas of responsibility include problem-solving, creating added value, standardizing, and improving manufacturing processes.
Initiate and manage deviations for production events within quality systems, ensuring timely resolution.
Evaluate the impact on equipment, products, and materials with input from relevant Subject Matter Experts (SMEs).
Conduct investigations of varying complexity using root cause analysis tools (e.g., DMAIC, Cause & Effect Diagrams, 5M).
Lead multidisciplinary investigation teams and workshops as needed.
Perform interviews to analyze deviations related to human factors.
Compile data and write investigation summary reports.
Define and implement robust corrective and preventive actions (CAPA).
Monitor CAPA effectiveness and ensure timely closure of records.
Provide technical expertise in manufacturing processes relevant to the subgroup (PUT).
Independently follow up on deviations to ensure timely completion.
Propose technical and organizational solutions to address issues.
Provide accurate reporting to follow-up platforms.
Present findings and issues to senior management and other sites.
Serve as SME during internal and external audits.
Identify and propose opportunities for improvement within and beyond deviations scope.
Lead or participate in continuous improvement initiatives for manufacturing processes.
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).
Demonstrated experience in deviation management using Six Sigma tools.
Familiarity with cGMP manufacturing environments and Quality/Compliance requirements.
Strong proficiency in cGMP environments and manufacturing operations.
Knowledge of engineering designs, automated documentation, and biotechnological processes (USP, DSP, FF).
Experience in deviation management and Six Sigma methodologies.
Cross-functional thinking and collaboration with SMEs.
Excellent oral and written communication skills.
Proficiency in French and English (written and oral).
Experience with QMS and computerized systems (e.g., Trackwise, ERP, Veeva Vault).
Mastery of MS Office Suite (Word, Excel, PowerPoint, Visio).
Knowledge of statistical software (e.g., MiniTab) is a plus.