Manufacturing Engineer

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 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

• * 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)

* Deviation report out

• Proactive and autonomous follow-up of deviations under responsibility (including identification of potential issues/bottlenecks) to ensure timeliness 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

* Continuous improvement

• Identify opportunities and propose ideas for improvement, in and ouf of deviations scope (including technical and organizational solutions)
• Lead or participate to 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 (e.g. DMAIC, Is/Is Not, Cause & Effect Diagram, 5M, Contradiction Matrix, etc.)
• Experience of Quality/Compliance requirements within cGMP manufacturing environment

Critical / Key skills

• 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
• 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 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

Complexity and Problem Solving

• Manage its 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 his/her training plan to ensure compliance with the tasks performed

Internal and External Contacts

• Organize autonomously the collection of necessary information to conduct its tasks with all internal partners as well as with external partners (other sites of the group, suppliers)
• Able to adapt the level of information and communication according to its target audience (audit, Senior Leadership Team, manufacturing personnel, inter and intra-services exchanges)

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 (PUT)

If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar elaine.kanwar(at)experis.ch or at +41 61 282 22 23