3 дня назад
Senior Fill Finish Process Engineer (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Fill Finish Process Engineer (Biotechnology): Providing technical leadership for aseptic fill-finish and sterile drug-product manufacturing systems at the Athlone site with an accent on facility-fit assessments, feasibility studies, capital planning, and engineering design. Focus on evaluating process and facility requirements, guiding capital projects through operational readiness, and coordinating global technical authorities with site stakeholders.
Location: Athlone, Ireland; on-campus, site-based role
Company
is a mid-sized biotechnology company developing life-changing medicines through regulated pharmaceutical manufacturing and engineering operations.
What you will do
- Serve as a subject matter expert for aseptic filling, sterile manufacturing, isolators, RABS, lyophilization, autoloading systems, and related drug-product technologies.
- Lead facility-fit assessments and feasibility studies for new products, technologies, facility modifications, capacity expansions, and manufacturing investments.
- Support capital projects from concept through operational readiness, including conceptual design, FEED, detailed design, construction, and stage-gate reviews.
- Review layouts, process flow diagrams, equipment specifications, utility assessments, and engineering design packages against GMP and standards.
- Coordinate Global Engineering & Facilities Technical Authorities with Athlone site stakeholders and provide local support for technical assessments and operational issues.
- Assess future manufacturing capabilities, support technology transfers, monitor emerging technologies, and drive engineering standards and continuous improvement.
Requirements
- Bachelor’s degree in Mechanical, Chemical, Industrial, Pharmaceutical, or a related Engineering discipline.
- Experience in pharmaceutical, biotechnology, medical device, or another regulated manufacturing industry.
- Experience supporting aseptic manufacturing operations, sterile processing technologies, facility-fit assessments, engineering evaluations, and feasibility studies.
- Experience supporting capital projects and facility modifications.
- Working knowledge of GMP requirements and pharmaceutical facility design principles.
- Strong communication, technical writing, presentation, and cross-functional stakeholder-influence skills.
Nice to have
- Experience with fill-finish facilities, sterile product operations, A&E consulting, FEED, conceptual design, or detailed design.
- Knowledge of isolators, RABS, lyophilization, material transfer systems, automated visual inspection, and contamination control strategies.
- Experience with packaging, finished goods, secondary manufacturing, or technology transfers.
- Master’s degree in Engineering or a related discipline.
- Professional Engineering registration or equivalent certification.
Culture & Benefits
- Work within a global biotechnology organization combining the stability and resources of an established company with opportunities for individual impact.
- Access learning, growth, and skills-development opportunities.
- Collaborate across global technical authorities, site engineering, operations, vendors, and external experts.
- Participate in an inclusive workplace focused on belonging, diverse perspectives, and delivering life-changing medicines.
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