Manufacturing Engineer
Vor 2 Tagen
Manufacturing Engineer - Pharma vacancy for a globally operating Neuchatel based company in the pharmaceutical sector.
Job Description:Within the Manufacturing department, reporting to Deviation Manager, the primary mission for the Manufacturing Engineer is to support the manufacturing operations to meet their goals in terms of quality and productivity. He/she specifically provides technical expertise needed to investigate deviations related to the manufacturing process and acts as a catalyst for continuous improvement. Main responsibilities are problem solving, creation of added value, standardization and improvement of manufacturing processes.
Your tasks:- While this is a day-time job, must be able to work on occasions in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- Lean/Six Sigma Certification(s) highly desirable.
- Manufacturing Engineer may be requested to manage deviation and provide technical expertise on subjects out of his/her own field of expertise to back-up Manufacturing Engineers from other sub-groups (PUT).
- Deviation management.
- Initiate and manage deviations within the framework of production events and within quality systems in a timely manner.
- Perform evaluations related to impact on concerned equipment/product/material with the support of relevant Subject Matter Experts (SME).
- Perform investigations of low, moderate and high complexity/severity using root cause analysis tools (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.).
- Lead multi-disciplinary investigation teams and associated workshops as appropriate.
- Perform interview in the frame of deviation related to human factors.
- Collect/compile data and write investigation summary reports.
- Define robust corrective and preventive actions.
- Identify relevant criteria to monitor efficacy of CAPA and ensure follow-up until closure of the record.
- Technical expertise on manufacturing processes relevant to sub-group (PUT).
- Bachelor/Master in Engineering and 3-5 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations or Quality).
- Technical knowledge of the biotechnological processes (USP and/or DSP).
- Ideally demonstrated experience in “deviation” management including use of Six Sigma tools (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.).
- Experience of Quality/Compliance requirements within cGMP manufacturing environment.
- Experience in computerized / automated / QMS systems (ex: Trackwise, ERP, Veeva Vault).
- Master MS Office suite (Word, Excel, PowerPoint, Visio).
- MiniTab or other statistics software is a plus.
- Proficiency in a cGMP environment.
- Strong knowledge in detailed manufacturing operations (e.g. engineering designs, automated documentation) and biotechnological processes (USP, DSP and/or FF).
- Experience in “deviation” management including use of Six Sigma tools.
- Ability to think and act cross-functionally, interacting with various SME.
- Written and oral proficiency in French and English.
- Analytical spirit and sense of detail.
- Able to manage priorities in fast paced environment.
- Strength of proposal and able to challenge the status quo.
- Flexibility and agility.
- Autonomy and ability to take initiatives in line with the site priorities.
- Proactivity in personal development.
Location: Neuchatel, Switzerland
Sector: Pharmaceutical
Start: 02/2025
Duration: 05MM+
Ref.Nr.: BH22512
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.
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