Experis is the global leader in professional resourcing and project-based workforce solutions.
On behalf of our Pharmaceutical company in Neuchatel, we are looking for a Manufacturing Engineer with experience in deviations related to Manufacturing processes.
Within the Manufacturing department, reporting to the 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.
Job Function and Description
* 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 interviews 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
* Provide technical expertise on manufacturing processes relevant to sub-group (PUT)
* Proactive and autonomous follow-up of deviations under responsibility to ensure timely completion of each step
* Propose technical and organizational solutions
* Accurate reporting to relevant follow-up platforms
* Ensure report out of findings/issues to high Management and other sites
* Act as SME during internal and external audits
* Identify opportunities and propose ideas for improvement, in and out of deviations scope
* Lead or participate in manufacturing process continuous improvement initiatives
Education and Experience Requirements
* 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
* Experience of Quality/Compliance requirements within cGMP manufacturing environment
Critical / Key skills
* Proficiency in a cGMP environment
* Strong knowledge in detailed manufacturing operations and biotechnological processes
* Experience in “deviation” management including use of Six Sigma tools
* Ability to think and act cross-functionally, interacting with various SME
* Excellent communication skills orally and written
Language & IT Skills
* Written and oral proficiency in French and English
* 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
Key Skills, Abilities, and Competencies, Personal qualities:
* Structured and rigorous
* Analytical spirit and sense of detail
* Able to manage priorities in a 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
Complexity and Problem Solving
* Manage portfolio of activities autonomously to guarantee deliverables
* Alert and inform hierarchy in case of conflict between several initiatives in a timely manner and propose alternatives, solutions, and/or options to deal with them
* Manage training plan to ensure compliance with tasks performed
Internal and External Contacts
* Organize autonomously the collection of necessary information to conduct tasks with all internal partners as well as with external partners
* Able to adapt the level of information and communication according to its target audience
Other Job Requirements
* 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
* If necessary, the 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
If this job interests you, please send us your CV today through the link in the advert. However, should you have any questions, please contact Elaine Kanwar at elaine.kanwar(at)experis.ch or at +41 61 282 22 23.
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