Shire DSP Process Engineer in Neuchatel, Switzerland

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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.