20 часов назад
Senior Technical Specialist, MFG (MM) - Fixed Term Contract (Biopharmaceutical Manufacturing)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Technical Specialist, MFG (MM) - Fixed Term Contract (Biopharmaceutical Manufacturing): Developing and managing GMP manufacturing documentation and operational readiness for technology transfers and process campaigns with an accent on Master Batch Records, SOPs, investigations, and CAPA. Focus on leading root cause analyses, coordinating cross-functional technical deliverables, and supporting compliant manufacturing execution in a biopharmaceutical environment.
Location: Tuas, Singapore
Company
is a global life sciences manufacturing company with more than 30 sites across five continents, producing medicines and supporting customers in developing breakthrough therapies.
What you will do
- Develop, revise, and manage Master Batch Records, SOPs, Change Requests, risk assessments, and other GMP manufacturing documentation.
- Coordinate operational readiness for technology transfers and process campaigns, including pre-campaign training and equipment and material qualification support.
- Lead manufacturing investigations covering deviations, trends, root cause analyses, product impact assessments, and CAPA development.
- Support deviation reviews, CAPAs, change controls, defective material management, audit preparation, and manufacturing technical assessments.
- Collaborate with Manufacturing, Quality Assurance, MSAT, Engineering, and customers on technical deliverables and regulatory compliance.
- Drive continuous improvement, strengthen documentation and data integrity, mentor junior team members, and provide technical support during inspections and audits.
Requirements
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry, Microbiology, Life Sciences, or a related scientific discipline.
- Experience in biopharmaceutical manufacturing, manufacturing support, technical operations, process engineering, MSAT, or GMP technical documentation.
- Strong experience authoring and managing Master Batch Records, SOPs, Change Requests, risk assessments, and other GMP-controlled documents.
- Understanding of manufacturing processes, GMP requirements, deviation investigations, CAPA management, root cause analysis, and manufacturing quality systems.
- Strong technical writing, documentation management, communication, presentation, analytical, and problem-solving skills.
- Ability to lead cross-functional projects, manage competing priorities, influence stakeholders, and mentor junior team members.
Culture & Benefits
- Agile career environment and dynamic working culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-based compensation programs.
- Opportunities to collaborate with global cross-functional teams.
- Ongoing learning and professional development opportunities.
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