Fabio Montagner

Experience

• 

  Anklin Metallbau AG

  Jul 2011 - Aug 2012

  Multi-discipline mechanic

  Main work in:-Working with materials-Written and oral reports-Managing client relationships-Working independently

• 

  Pradaschier AG

  Dec 2011 - Feb 2012

  Chairlift operator

  Main work in:Client contactMaintaining and improving the company’s high standards

• 

  Roche

  Jul 2013 - Aug 2013

  Multi- discipline mechanic

  Main work in:-Revision / Maintenance of valve-Installation of Valve

• 

  Roche

  Aug 2014 - Sept 2014

  Multi- discipline mechanic

  Special: Apprentice care (8 apprentices) Main work in:-Production on customer request-Conventional Work (Turning, drilling, milling)-CNC-Work (ISO Control, Fanuc 20 / 31i, Heidenhain 155)

• 

  Roche

  Aug 2015 - Sept 2015

  Multi- discipline mechanic

  Special: Apprentice care (8 apprentices) Main work in:-Production on customer request-Conventional Work (Turning, drilling, milling)-CNC-Work (ISO Control, Fanuc 20 / 31i, Heidenhain 155)

• 

  Roche

  Aug 2017 - Mar 2021

  Special: Supervisor, onboarding, operational excellence team lead, method transfer leader, single point of contact for medical products, responsible and expert for an analytical lab-Perform method validations and method transfers to quality control / manufacturing departments-Represent Verification Engineering as Single Point of Contact providing high-quality expertise, taking full responsibility for deliverables and related resource planning as well as completing activities in a timely and high-quality manner-Support and manage DHF documentation (e.g. requests, protocols and reports) -Excellent relationship and healthy network with, for example, line function partners, internal auditors, QA, vendors, CMOs and HFE to provide the best possible solution regarding, e.g., parts obsolescent, design improvements, engineering change requests, URS and new regulations-Provide specialist expertise to plan, coordinate and execute experimental non-GMP and GMP design verification testing (primary and secondary packaging)-Acquire and maintain in-depth understanding and clear overview of:o Norms and standards, design control activities (entire DHF), and the complete method portfolio (e.g. ISO 13485, 21CFR820, ISO14971)o Operational procedures, including conducting internal laboratory investigations, discrepancies and changes, as well as by acting as an expert for statistical techniques-Represent the department at internal conferences, including talks and presentations-Lean production / operational excellence 5S team leader-Fundamental leadership skills; manage interns and short-term apprentice, including recruitment as well as onboarding processes-Act as single responsible person for an analytical lab within the department- Show less

  • Corporate transformation & health analyst

    Sept 2020 - Mar 2021

  • Verification Engineer

    Aug 2017 - Aug 2020
• 

  Johnson & Johnson

  Jun 2021 - Nov 2021

  Consultant: Project Engineering/Leader

  Project engineer/leader at Jansen (Johnson & Johnson):First mission: Refurbishment of an entire development building to a GMP Ready production building. Project budget was approximately CHF 13 Million.Second mission: Data center remediation and it covered a budget of approximately CHF 1 Million.➢Manages and supports end-to-end delivery within assigned annual CAPEX investment projects leveraging best practices, and applying internal as well as external partnerships to safeguard project success (i.e. fulfillment of defined FPO’s and/or budget, timeline and requirements)➢Provides technical guidance within assigned projects from idea generation to close-out and lessons learned to achieve best-in-class project delivery and optimized organizational learning➢Guarantees that project engineering and associated efforts are in full compliance with all applicable regulations, procedures and standards➢Assists in document lifecycle within the assigned projects according to defined processes➢Organizes and leads day-to-day business of the assigned project resources/teams in agreement with project leader➢Assists in technical resolution of issues that may arise within project scope including troubleshooting, root-cause analysis and investigations in case of technical, quality or safety events, incidents and/or accidents➢Responsible for continued alignment with internal customers, business partners and stakeholders -->Responsibilities also include Customer Relationship Management, Supplier Relationship Management, Safety and EHS Compliance within assigned projects➢Supports regular project-related self-inspections, continuous monitoring and spot checks to identify gaps or potential situations of non-compliance including remediation and follow-up for sustainable effectiveness➢Provides project related info for document management and quality event tracking systems (e.g. Change Controls) Show less

• 

  Lonza

  Jan 2022 - Jun 2023

  Associate Principal Scientist - Primary Packaging Portfolio and Holistic CCI Strategy Lead