Senior Pharmaceutical Engineer II

vor 2 Monaten

Baar, Zug, Schweiz Biogen Vollzeit

About This Role

This individual contributor within the Pharmaceutical Engineering Technical Authority function is accountable for subject matter expertise in small molecule and to a lesser extent in antisense oligonucleotide (ASO) modalities. The ideal candidate will possess engineering experience and knowledge of process equipment and facility design in both small molecule API as well as small molecule OSD pharmaceutical production.

Key Responsibilities

  • Own strategic technical direction for all types of assets within small molecule engineering.
  • Work across functions and globally to provide technology support to facility, manufacturing projects and site operations by combining engineering principles, facilities knowledge, and design experience to lead the development of value-added technical designs, solutions, and best practices.
  • Pursue intentional, strategic collaborations with external stakeholders and peers in industry.
  • Develop relationships and liaise with Academia and Industry Key Opinion Leaders to provide vision to develop transformative approaches to Biogen manufacturing operations technology and solutioning.
  • Lead / execute benchmarking exercises to inform our stats relative to industry and provide context for improvement opportunities.
  • Serve as a key innovation catalyst within Biogen.
  • Working with internal and external stakeholders, expectation will be that experts within this function continuously acquire and maintain cutting edge knowledge of concepts, standards, technologies, and applications for the life science industry and apply such to our global engineering systems where applicable.
  • Leading innovation involves constantly exploring and implementing new technologies and strategies to optimize factory performance, capacity, throughput, energy efficiency, sustainability, execution speed, and other measures to meet the evolving needs of Biogen.
  • Accountable for execution of activities in support to front-end planning and execution of capital projects.
  • Lead technical inputs/activities for capital front end planning of potential project opportunities introducing new / advanced technologies.
  • Lead technical ownership of long range planning, tech maps, feasibility studies, and scope definition.
  • Provide technical leadership on capital projects introducing new / advanced engineering technologies as required and ensure capital projects align with small molecule technical standards and requirements via design reviews and site confirmations.
  • Support technical assessment on any new or revised business development opportunities.
  • Ensure that reliability is integrated into the design, construction, and operation of new facilities, equipment, and systems.

Requirements

  • A minimum of 8 years' experience in Process Engineering in Biotech, Pharma or equivalent industry.
  • Knowledge of small molecule API, small molecule OSD, and a plus is having ASO engineering experience including asset lifecycle management practices within the modality; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning / qualification / validation.
  • Experience with an A/E consulting firm is preferred but not essential.
  • Expert knowledge and application of FDA and EMEA regulations.
  • Excellent leadership, people management, organization, communication, and inter-personal skills are required.
  • Advanced ability to influence individuals at both site and global level.
  • Strong communication and presentation skills.
  • Understanding of asset lifecycle data analytic concepts and methods.
  • Already established network of technical leaders, peers, and stakeholders in life science industry; Actively participates in industry forums, etc.

Education

BS in Chemical Engineering or related process engineering discipline

MS or PhD in engineering discipline is strongly preferred but not required

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