9 дней назад
Engineer 2 - Process Development (Manufacturing Technology & Transfer)
82 500 - 123 700$
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Описание вакансии
Текст:
TL;DR
Engineer 2 - Process Development (Manufacturing Technology & Transfer) (genomics manufacturing): Developing and transferring reagent formulation, fill, and assembly processes for pilot-plant and high-volume manufacturing with an accent on GMP production, process validation, and cross-functional technology transfer. Focus on designing controlled experiments, optimizing yield and quality, troubleshooting manufacturing processes, and implementing lyophilization and liquid-handling solutions.
Location: San Diego, California, United States
Salary: $82,500–$123,700 per year, plus eligible bonus, commission, and equity programs.
Company
develops genomic technology and sequencing products that support disease detection, diagnosis, treatment development, and health research.
What you will do
- Develop and improve reagent formulation, filling, assembly, and other manufacturing processes for consumable sequencing products.
- Represent Operations in product development and transfer initiatives, partnering with Product Development, Manufacturing, Quality, Supply Chain, EHS, Facilities, and engineering teams.
- Define manufacturing process and equipment requirements; design, develop, and source production equipment from vendors and OEMs.
- Author procedures and work instructions for new GMP manufacturing processes and train production operators.
- Lead pilot-plant builds, controlled experiments, DOE studies, process troubleshooting, and technical investigations focused on yield, quality, and throughput.
- Transfer process knowledge into manufacturing and sustaining support teams for product launches and high-volume production.
Requirements
- On-site work in San Diego, California, United States.
- B.S., M.S., or Ph.D. in Mechanical Engineering, Chemical Engineering, Materials Science, Bioengineering, or a related field, with 2–4 years of relevant experience.
- Experience in production, pilot-plant operations, or process development using GMP practices and techniques.
- Experience with product development, design transfer, process and equipment validation, and manufacturing process improvement.
- Strong problem-solving, analytical, organizational, written, and verbal communication skills, with the ability to work across departments.
- Experience with statistics, statistical process control, DOE, cGMP, 21 CFR 820, ISO 13485, or ISO 14971 is relevant to the role.
Nice to have
- Experience with lyophilization cycle development, excipient and formulation development, or lyophilization manufacturing support.
- Knowledge of liquid handling and automation platforms such as Hamilton Robotics or Tecan.
- Experience in high-volume consumables manufacturing, project management, or process improvement methodologies including 6 Sigma, DFSS, 8D, and DMAIC.
Culture & Benefits
- Health, dental, and vision coverage, family-planning support, retirement benefits, and paid time off.
- Access to genomics sequencing and career development opportunities through Employee Resource Groups.
- Inclusive, collaborative work environment focused on openness and diverse perspectives.
- Employment is subject to a background check after a conditional offer.
- This role is not eligible for visa sponsorship.
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