Manufacturing Engineer FF

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Job Description

Job Title: Manufacturing Engineer

Location: CHE - Neuchâtel

Primary Duties :

Within the Manufacturing department, reporting to Deviation Experts Supervisor, 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.

Responsibilities:

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

Coaching

·Coaching and training of new arrivals and colleagues

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 (Compétences critiques / clés):

·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 (Compétences linguistiques et informatiques):

·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 necessary, the Manufacturing Engineer may be requested to play the role of supervisor as back up for technical aspects.

En savoir plus sur Takeda Neuchâtel:

Avec plus de 700 collaborateurs, Takeda Neuchâtel est l’un des dix plus grands employeurs du Canton de Neuchâtel et l’un des sites de production biopharmaceutique de référence en Suisse. Actif 24 heures sur 24 et 7 jours sur 7, le site emploie un large éventail de professionnels formés aux biotechnologies et à leur application dans la production industrielle.

Avec plus de vingt nationalités, Takeda Neuchâtel offre un environnement de travail international, diversifié et innovant au sein d’une entreprise ancrée et engagée dans son écosystème local.

Takeda Neuchâtel est certifiée Entreprise Formatrice par le Secrétariat d'Etat à l'Economie Suisse. Nous formons des jeunes apprentis dans divers domaines tels que le contrôle qualité en laboratoire, la logistique, l’informatique et la production biopharmaceutique.

“Donner à nos employés les moyens de briller”:

Takeda est fière de son engagement à créer une main-d'œuvre diversifiée et à offrir des opportunités d les employés et candidats à l'emploi sans tenir compte de la couleur de peau, de la religion, du sexe, d sexuelle, de l'identité de genre, de l'expression de genre, du statut parental, de l'origine nationale, de l statut de citoyenneté, des informations ou caractéristiques génétiques, de l'état civil ou de toute autre protégée par la loi.

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