9 дней назад
Process Engineer II - Equipment Engineering (Biotechnology)
99 705 - 129 030$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Process Engineer II - Equipment Engineering (Biotechnology): Supporting the lifecycle, reliability, qualification, and compliance of manufacturing, laboratory, and facility equipment used in cell therapy production with an accent on GMP operations, troubleshooting, and cross-functional equipment ownership. Focus on analyzing equipment failures, implementing CAPAs and change controls, improving maintenance strategies, and supporting commissioning and qualification of new systems.
Location: Frederick, Maryland, United States; onsite at a cell therapy manufacturing facility
Salary: $99,705–$129,030 annually, plus potential discretionary bonus, stock-based incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing cancer immunotherapies, including CAR T-cell and TCR-engineered cell therapies.
What you will do
- Support the operation and lifecycle management of manufacturing, laboratory, and facility equipment.
- Own equipment assets in the Enterprise Asset Management System and support repairs, maintenance, investigations, and troubleshooting.
- Analyze equipment failures, maintenance records, and performance trends to identify reliability improvements.
- Support CAPAs, change controls, engineering assessments, technical reports, and regulatory inspections.
- Assist with specification, procurement, installation, commissioning, and qualification of new equipment.
- Collaborate with Manufacturing, Quality, Validation, Maintenance, Supply Chain, and vendors on reliability, compliance, capacity, safety, and operational efficiency.
Requirements
- Bachelor’s degree in Engineering, such as Chemical Engineering, Mechanical Engineering, Bioengineering, or a similar discipline.
- 3–5 years of engineering experience in biotechnology, pharmaceutical, medical device, or another regulated industry.
- Strong analytical, problem-solving, written, and verbal communication skills.
- Ability to work effectively in cross-functional teams.
- Experience with equipment maintenance, troubleshooting, or validation activities.
- Experience with cell therapy manufacturing equipment, automated manufacturing platforms, laboratory instrumentation, cryogenic storage, or filter integrity testing systems is relevant.
Nice to have
- Familiarity with GMP manufacturing environments.
- Experience with equipment reliability initiatives, maintenance optimization, or spare parts strategies.
Culture & Benefits
- Work in a state-of-the-art cell therapy manufacturing facility focused on cancer treatment development.
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
- Paid time off and potential annual bonus and stock-based long-term incentives may be available.
- Inclusive workplace with emphasis on collaboration, development, empowerment, safety, quality, and compliance.
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