Manufacturing Process Engineer

Shire

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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Shire grew its organization to approximately 23,000 employees+ globally, following integrations of Dyax and Baxalta.

An exciting and challenging opportunity has become available at Shire Neuchâtel Plant (approx. 650 employees) for an experienced Manufacturing Process Engineer to join our Advate Manufacturing team

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile manufacturing professional to embrace a team-based culture and more specifically within the manufacturing teams within a world-class Biotech manufacturing environment.

Job summary

Within the Manufacturing Advate departement, the purpose of this role to provide the technical expertise needed to investigate deviations within the manufacturing process and to act as a catalyst for continuous improvement.

Essential duties and responsabilities

  • Initiate and lead investigations within the framework of production events/deviations and monitor appropriate quality systems (i.e. Trackwise)
  • Writes product impact evaluations and determine corrective actions, as well as quality documentations (SOP, RS, etc…).
  • Act as a Subject Matter Expert (SME) during internal and external audits for selected topics
  • Initiate and lead Change Control and monitor appropriate quality systems
  • Actively participate in problem solving using QLP tools
  • Investigate Outliers detected during the process control in collaboration with the PDTS(”Process Development Technical Sciences”) department
  • Participate in Workshops (i.e. Kaisen) and participate to manufacturing process improvement and/or enhancement projects
  • Writes, reviews and executes validation protocol’s and provides support to the manufacturing operational teams
  • Incorporates and respects cGMP concepts (Good Manufacturing Practices).
  • Act as a Documentation Owner and Technical Expert when modifying Manufacturing documents 

Qualifications

  • Strong knowledge and interest in detailed manufacturing operations (e.g. engineering designs, automated documentation).
  • Ability to think and act cross-functionally, interacting with experts, SME’s, engineers etc.
  • Structured/Systems thinking with good technical understanding
  • Good leadership and interpersonal skills, self-motivated, capable of analyzing and solving complex problems through innovative thought and experience
  • Able to work in a fast and dynamic environment with a high emphasis on achieving results
  • Must be able to provide solutions that reflect an understanding of business objectives and cost implications
  • Excellent communication & listening skills, can adapt style to the audience.
  • Team player prepared to work in, and embrace a team-based culture and more specifically within the manufacturing teams
  • Demonstrated ability in technical writing, describing complex processes and qualificationsand to translate it into clear, precise reports
  • Able to convince management on courses of action with minimal assistance using both written and verbal methods
  • Fluent in English and French

Education & Experience

  • Bachelor/Masters in Engineering and 5-8 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations or Quality) or PhD and >4 years of experience
  • Demonstrated experience in “deviation” treatment (minimum 5 years)
  • Expertise in Quality/Compliance within an FDA regulated/GMP manufacturing setting
  • Experience with Six Sigma DMAIC tools (e.g. Is/Is Not, Cause & Effect Diagram, Contradiction Matrix, etc.)
  • Sound knowledge of cellular culture and chromotography processes procédés de cultures cellulaires et chromatographies.

Working Environment:

While this is a day-time job, must be able to work on occasions in controlled environments (ISO 5, ISO 7 and ISO 8 environments ; grade A, B, and C) requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:

  • Be Positive
  • Be Accountable
  • Be Results Oriented
  • Be An Excellent Manager of Self and Others
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Confirmed 9 hours ago. Posted 30+ days ago.

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