10 дней назад
Senior Engineer I – Process Engineering (New Product & Technologies/ GLAM/ Site Projects) (Biotech Manufacturing)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Engineer I – Process Engineering (New Product & Technologies/ GLAM/ Site Projects) (Biotech Manufacturing): Leading process equipment readiness for new product and technology introductions, GLAM, and site projects at the Singapore biotechnology/API manufacturing facilities with an accent on equipment design, commissioning, qualification, and validated-state compliance. Focus on solving complex equipment reliability and operational challenges, coordinating cross-functional engineering projects, and developing system owners and subject matter experts.
Location: Singapore Manufacturing – Tuas; onsite role
Company
develops medicines for patients with serious illnesses by combining biological science and technology.
What you will do
- Lead process equipment readiness for new product and technology introductions, GLAM, and site projects across ASM1 and ASM2.
- Act as technical project lead and system owner for biotechnology and API manufacturing equipment.
- Lead equipment design, modification, commissioning, qualification, automation checkouts, and system takeover activities.
- Partner with project management, manufacturing, quality, validation, maintenance, reliability, facilities, and other technical functions.
- Assess equipment and facility gaps, utilities capacity, layouts, project costs, schedules, and technical risks.
- Improve equipment reliability, maintenance strategies, predictive monitoring, and operational sustainability.
Requirements
- Doctorate in Engineering or a related discipline; or a master's degree with 2 years, bachelor's degree with 4 years, or diploma with 8 years of directly related experience.
- Experience managing stakeholders and process equipment in biopharmaceutical or API manufacturing.
- Knowledge of biopharmaceutical processes including chromatography, buffer and media tanks, viral filtration, tangential flow filtration, inoculation, bioreactors, harvest, single-use technologies, API processes, and critical utilities.
- Experience with validation and qualification documentation, including Installation, Operation, and Performance Qualification.
- Knowledge of automation systems such as DeltaV, BMS, ladder logic, and PLCs.
- Strong communication, analytical, facilitation, problem-solving, and project management skills; flexibility to work off-hours is required.
Nice to have
- Knowledge of Total Productive Maintenance and Reliability Centered Maintenance concepts.
Culture & Benefits
- Collaborative environment with cross-functional and worldwide engineering interactions.
- Opportunities for professional development, coaching, mentoring, and technical leadership.
- Competitive benefits and development opportunities supporting professional and personal growth.
- Medical checks required for the role are arranged with related expenses covered by .
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