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Process Engineer Senior

  • Job reference: 928608
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 11/11/2019

Orion Group Sciences are looking for a Process Engineer (Senior) for our multinational pharmaceutical client based in the South of Dublin area on an initial 18-month contract with the potential to extend.


The Process Engineer provides process development technical support to large molecule and small molecule drug product manufacturing as well as being part of the global Process Development organisation. The input provided will include support of process performance and implementation of process improvement strategies:
* Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for parenteral products.
* Provides process development expertise for commercial drug product processing in specific areas such as Sterile processing, Process Characterisation, Tech Transfer and Validation. Supports commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Adopts a customer-centric interface with manufacturing, and all partner support functions, to provide robust and coordinated support to manufacturing.
* Troubleshoots issues with drug product processing technologies and equipment. Champions' use of data-driven analyses and visualisations. Investigates to determine true root cause.
* Develops and characterises drug product processes and transfer technology to commercial drug product sites.
* Conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
* Identifies and implements operational opportunities for current and new sterile operations.
* Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Be a link to manufacturing on key investigations as a process expert.

Basic Qualifications:
* Bachelor's degree & 10 years of directly related experience.
OR
* Master's degree & 6 years of directly related experience.
* Associate's degree & 15 years of directly related experience.

Preferred Qualifications:
* Direct industrial experience in the field of lyophilisation, specifically related to cycle development, scale up & technology transfer, in-silico modelling & optimisation, commercial support, process monitoring and troubleshooting (i.e. product impact assessment of process excursions).
* Masters in Science or Chemical Engineering
* 10 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transfer (to commercial DP sites) or Validation.
* Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability
* Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
* Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
* Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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