Process Engineering, Sterile Injectable SME
Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Process Engineering, Sterile Injectable SME to join a global top 10 pharmaceutical company, the location of this role is flexible and can be based in multiple sites across the world including Belgium, Sweden, Ireland, Italy. Spain, India and the USA.
The successful candidate will be responsible for providing Process Engineering technical support across the company network and capital project portfolio.
The role will be primarily focused on the Aseptic and Sterile Injectable technologies. The Process Engineering and Analytics team provides Subject Matter Expert (SME) input into process engineering, process modelling and data analytics support to API, Biologics, Sterile Injectable and Solids process operations throughout the company. The purpose of this role is to provide Aseptic/Sterile Injectable specific process engineering and equipment knowledge into production facility designs, process equipment selection, process design, operational troubleshooting and ongoing operational support across all Sterile/Aseptic operations (including DS and DP processing)
Provide process and equipment engineering SME input into the Aseptic/Sterile Injectable network ensuring best known methods and state of the art design practices are used. Providing the linkage between multiple projects and leveraging the wider network experience to ensure both robust and reliable aseptic/sterile processing throughout the network.
- New Technology - Develop & evaluate new technologies related to sterile and aseptic processing
- Provide technical guidance to the company network in relation to:
- Development of site equipment master plans with a longer-term focus (typically 3 to 5 years) based on the organization's vision.
- Equipment Selection - Identify suitable technologies & suppliers to meet user requirements, support new product launches and on-going capital investments
- Support the development of validation plans related to sterilization and Aseptic processing of products.
- Support product submissions/filings/dossiers for sterilization and aseptic processing related sections (example CTD 3.2.P.3)
- Provide SME support for regulatory actions (internal and external) and provide recommendations for process/procedure updates.
- Design and execute sterilization development studies to support current process/products, as appropriate
- Equipment knowledge & SME input related to sterilization/aseptic operations
- Troubleshooting - Provide technical support for major supply or quality issues relative to sterilization and aseptic process related issues for product and/or processes
- Partner with MAS in development/revisions of internal documents.
- Play an active role in promoting knowledge sharing and technology replication by participating in a broad range of global network teams, user groups, network strategies, vendor technology meetings, etc.
- Promote an Innovation Culture leveraging Innovation tools and behaviours
- Vendor Relationships / Management - Strengthen partnerships with key vendors to facilitate issue resolution, after sales support, etc.
- Communicate proactively with stakeholders, senior leaders and sites regarding activities, progress, issues and resolution plans related to supported activities.
- Collaborate with process automation, equipment engineering, and other technical groups to optimize process robustness and asset performance
- Support development and application of tools and systems to enhance product and process knowledge throughout the product lifecycle.
Skills and Requirements:
- Bachelor Degree in Engineering or equivalent scientific discipline
- Master Degree in Engineering or
- 5 - 10 years of experience in the Pharmaceutical / Biologics Manufacturing operations with an in-depth knowledge of Aseptic/Sterile Injectable processes and regulatory requirements.
- Proven ability to work in a cross-cultural environment and provide technical leadership while working remotely is required.
- Extensive background in Aseptic/Sterile Injectable processes and a clear understanding of the associated regulatory requirements.
- Exceptional communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders and technical leaders.
- Ability to lead technical programs and initiatives, fostering support from stakeholders and collaboration among participants.
- Proven ability to work in a cross-cultural environment and provide technical leadership while working remotely is a requirement.
- Expected to continue to develop skills to maintain subject matter expertise
- Up to 35% international travel
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alexander Tooulas on +44 207 437 6824 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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