3 days ago

TS Process Engineer


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TS Process Engineer

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 24,000 employees+ globally, following integrations of Dyax and Baxalta.

An exciting and challenging opportunity has become available at the Shire Neuchâtel Plant (approx. 650 employees) for a high skilled DSP (Downstream Process) process engineer with validated experience in purification processes and recombinant protein, ensuring process performances for 2 recombinant API.

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Process Developpment & Technical Services (PDTS) team within a world-class Biotech manufacturing environment.

Job summary

PDTS is owner of the process hence this team of SME's (Subject Matter Experts) is a key player for all complex issues or projects involving the product. The jobholder will support Manufacturing and Quality departments regarding impact assessment, investigation and troubleshooting. The jobholder could also lead projects related to process improvement and technology transfer from or to other Shire facilities.

Essential Duties and Responsibilities

  • Lead investigations related to deviation/CAPA process
  • Perform product impact assessment for deviation
  • Lead process/ equipment improvement projects or activities (from User Requirements Specifications to Process Performance Qualification)
  • Develop and optimize process parameters
  • Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
  • Act as an accountable partner and take into account the business objectives within a matrix organization
  • Identify business opportunities
  • Ensure communication and act proactively in case of performance trending
  • Support validation activities
  • Support or present topic during regulatory inspections
  • Support technology transfer

Education & Experience

  • Engineering or university degree (minimum MSc)
  • Minimum 3-5 years of experience in protein purification (DSP) ideally in process development/ manufacturing support
  • Extensive theoretical knowledge of proteins and chromatography/ UF (Ultrafiltration) process
  • Knowledge of current Good Manufacturing Practices (cGMP) and quality requirements
  • Able to deal with statistics (six sigma experience)
  • Fluent in English and French
  • Analytical and problem solving skills
  • Ability to make data driven decisions promptly and appropriately on complex situations
  • Good training and communication skills

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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Pierre-à-Bôt 111 2000 Neuchâtel