Total Base Pay Range: 47,100.00 - 67,300.00 - 87,500.00 EUR
Naast het basissalaris kun je, afhankelijk van vooraf bepaalde prestatiecriteria, in aanmerking komen voor een prestatiegerichte bonus.
Responsibilities
Afhandeling van OOx/deviaties, definiëren van CAPA’s en opvolgen van KPI-trends
Ervoor zorgen dat alle activiteiten voldoen aan cGxP, inclusief data-integriteitscontrole en goedkeuring van analytische data/tests (analytische vrijgave) en stabiliteit
Stabiliteitstesten binnen projecten: opstellen van protocollen, evaluaties en rapporten
Rapportage, waaronder het opstellen van stabiliteitsplannen, trendanalyses en evaluaties
Uitvoeren van stabiliteitsstudies, protocollen en vergelijkende rapporten voor leverancierskwalificatie
Requirements
Bachelor's degree in Pharmaceutical Laboratory Technology, Microbiology, Biotechnology, Chemistry or another relevant scientific discipline
Provide technical expertise in aseptic drug product manufacturing, design and execute studies, support technology transfers, lead investigations, and drive continuous improvement in GMP manufacturing.
Compensation
Engineer III (Salary Range: $81,000.00 - $105,000.00)
Sr. Engineer I (Salary Range: $98,000.00 - $127,000.00)
Responsibilities
Provide technical expertise in aseptic drug product manufacturing, including formulation, sterile filtration, aseptic filling, visual inspection, and associated drug product processes
Design, plan, execute, and document laboratory and manufacturing support studies to improve process robustness, enhance process understanding, and troubleshoot manufacturing issues
Lead or support drug product technology transfers into GMP manufacturing
Partner cross-functionally with Technical Development, Engineering, Quality, Validation, and Manufacturing Operations to support commercial production and continuous improvement efforts
Serve as a technical SME for manufacturing investigations, performing root cause analyses and implementing effective corrective and preventive actions (CAPAs)
Requirements
Bachelor’s degree in relevant scientific or technical fields from an accredited college or university
Nice to have: Demonstrated experience supporting aseptic filling, sterile filtration, formulation, or other drug product manufacturing processes
Nice to have: Experience with Process Validation, aseptic process simulations (media fills), and sterile manufacturing best practices
Senior Engineer, Firmware Development (SSD) supports the development, validation, optimization, and debugging of high-performance SSD controller firmware for volatile and non-volatile memory solutions.
Responsibilities
Develop firmware IP subsystems for SSD products to meet performance, endurance, capacity, functionality, quality, and reliability requirements.
Execute firmware development, integration, bench testing, debugging, and validation activities for SSD controllers and storage products.
Perform root cause analysis, failure triage, and defect isolation; document findings and support corrective actions.
Develop and maintain firmware unit, functional, and integration tests to ensure quality and performance objectives are met throughout the product lifecycle.
Collaborate with hardware, validation, system, and product engineering teams to resolve complex development issues and improve product readiness.
Requirements
B.Sc. in Electrical Engineering, Computer Engineering, Computer Science or equivalent
Senior Engineer, Firmware Development (SSD) supports the development, validation, optimization, and debugging of high-performance SSD controller firmware for volatile and non-volatile memory solutions.
Responsibilities
Develop firmware IP subsystems for SSD products to meet performance, endurance, capacity, functionality, quality, and reliability requirements.
Execute firmware development, integration, bench testing, debugging, and validation activities for SSD controllers and storage products.
Perform root cause analysis, failure triage, and defect isolation; document findings and support corrective actions.
Develop and maintain firmware unit, functional, and integration tests to ensure quality and performance objectives are met throughout the product lifecycle.
Collaborate with hardware, validation, system, and product engineering teams to resolve complex development issues and improve product readiness.
Requirements
B.Sc. or higher in Electrical Engineering, Computer Engineering, Computer Science or equivalent.
Owns and optimizes manufacturing value streams for medical device production, leading process development, validation, and continuous improvement initiatives.
Responsibilities
Own and optimize assigned manufacturing value streams
Provide strategic technical leadership
Direct complex process development and validation programs
Lead multi‑functional continuous improvement initiatives
Influence long‑term process and equipment strategy
Requirements
Bachelor’s degree in Engineering (Mechanical, Chemical or Automation)
Experienced contractor to support business and technology initiatives, focusing on requirements management, SDLC, project delivery, testing and documentation within regulated environments.
Responsibilities
Gather, document, and maintain business and system requirements in partnership with business and technical teams.
Support project activities across the SDLC, including testing, deployment, change management, and required project and compliance documentation.
Track risks, issues, dependencies, action items, and project deliverables; escalate concerns as needed.
Support requirements traceability, validation, and user acceptance testing.
Collaborate with business stakeholders, project leads, and technical teams to deliver project objectives.
Senior Engineer - Firmware Development (SSD)Micron Technology · Singapore, Singapore