Process Tech Transfer Engineer
Brabant Walloon – Contracting
Our partner is currently looking for a Process Tech Transfer Engineer. Our partner is an international pharmaceutical company.
What are your responsibilities?
Process Tech Transfer for mammalian biotechnological manufacturing processes:
- Support process technology transfers between commercial plants, and support process validations in new plants.
- Support process technology transfers from Development to Internal Manufacturing & CMOs and support commercial-scale process validation.
- Support the technology transfer activities in terms of:
- Definition of the Tech Transfer and process control strategy in collaboration with sending unit,Quality Assurance, Industrial Leads and other identified stakeholders,
- Writing risk assessments, protocols, change controls, Tech Transfer reports, as well as technical reports for the execution of Tech Transfer runs for new processes,
- Coordination of sampling and analyses with the manufacturing teams, as well as external laboratories, sending unit and Analytical Transfer & QC Readiness team.
- Ensuring adherence to project planning.
- Support the MSAT Bio Process Heads for tasks such as:
- Review of documentation in Source CD,
- Preparation and carry-out of Health Authority (HA) inspections.
Validation & Continued Process Verification (CPV) of mammalian biotechnological manufacturing processes :
- Support process validation activities, including the definition of the validation strategy:
- Drive and write risk assessments and change controls for current and new processes as a manufacturing process expert,
- Write validation plans, protocols and reports in adherence with planning,
- Ensure adherence of the process validation activities to the applicable documents (VMP, procedures, guidelines, etc.).
Operational Support for mammalian biotechnological manufacturing processes:
- Provide routine support for manufacturing campaigns, CPV, process and equipment performance trending, new equipment or raw material qualification, first-line troubleshooting and second-line
troubleshooting for CMOs. - Support periodic reviews and Health Authority (HA) inspections,
- Support filings of Prior Approval Supplement (PAS) submissions.
Process improvement & COGS reduction for mammalian biotechnological manufacturing processes:
- Participate in the continuous improvement of Tech Transfer, process validation & CPV documentation and processes, including writing and coordination of Change Controls.
- Monitor commercial manufacturing and identify improvement opportunities within the limits of the approved parameters.
- Coordinate testing at small scale, validate, and implement process improvements within the limits of approved parameters, including review of protocols and reports for small-scale studies.
- Liaise with development teams to provide feedback on platform process performance and/or request 2nd gen. process development.
- Participate to deviations and Change Controls as SME for Tech Transfer/validation/CPV-related subjects and provide process expertise where needed.
- Participate as SME in technical or organizational cross-functional projects, as well as in specific manufacturing projects for activities related to process Tech Transfer, validation and CPV.
- Collaborate with the MSAT Lab team during complex process-related deviations and investigations.
- Collaborate with the MSAT Process Leads during projects.
- Support improvement projects within the group.
Quality:
- Work according to cGMP requirements.
- Perform all trainings in the defined deadlines, in order to ensure continued and complete state of training for Tech Transfer/validation/CPV activities.
- Use and ensure the use of authorized documents for all activities.
- Ensure that all validation/CPV/verification documentation (reports, sops…) is up-to-date and inspection ready.
- Present the validation/CPV/verification documentation during inspections and audits by partners and
Health Authorities (HA).
HSE:
- Actively take part in the application of the HSE policy (Health, Safety and Environment): respect of
HSE rules (procedures, wear of Individual Protection Equipment, systematic use of safety elements). - Signal events (incidents and accidents) linked to HSE,
- Promote HSE processes within the team and to colleagues from other groups.
To contribute significantly to the construction of a responsible business approach that takes sustainability into
- account at all levels (environmental/economic/societal), I am committed to integrating UCB's ambitions for:
- Diversity, equity and inclusion,
- Business health management (physical, social and mental health),
- Environmental policy,
- Ethics and Compliance,
- Patient Value Added Culture (PVS),
- Expected Behavior of Leaders.
Who are you?
- Master’s degree in biology, biotechnology or other lifesciences-related field
- Strong leadership skills,
- High level of spoken and written French and English,
- High understanding of biotechnological manufacturing processes,
- Good level of proficiency with MSOffice tools,
- Basic knowledge of statistics,
- Excellent communication skills, for communicating with internal and external partners,
- Ability to scope, research and understand complex subjects related to biotech
manufacturing, - Ability to structure ideas quickly and clearly,
- Excellent organization and problem-solving skills,
- Ability to define objectives and how to reach them,
- High capacity to anticipate issues, identify priorities and make decisions,
- High level of autonomy and good stress management skills,
- Solution-oriented and sensitive to customer needs,
- Pragmatic and critical-minded,
- Sense of responsibility and ownership,
- Sense of initiative,
- Team player.
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
