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Senior Process Engineer (Biopharmaceutical Manufacturing)
115 495 - 156 257$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Process Engineer (Biopharmaceutical Manufacturing): Designing, building, commissioning, and qualifying equipment and systems for drug substance production with an accent on downstream process engineering, GMP compliance, and equipment ownership. Focus on troubleshooting production systems, leading root cause analysis, implementing corrective actions, and supporting reliable 24/7 plant operations.
Location: Holly Springs, North Carolina, United States
Salary: $115,494.60–$156,257.40 per year
Company
is a biotechnology company developing treatments and operating advanced drug substance manufacturing facilities.
What you will do
- Design, build, commission, qualify, and support equipment and systems for drug substance production, with a focus on downstream process engineering.
- Own biopharmaceutical process equipment and lead system improvements, upgrades, modifications, and capital project implementation.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable plant operations.
- Develop maintenance programs, manage spare-parts availability, and coordinate maintenance activities.
- Provide technical troubleshooting, lead root cause analyses, and implement corrective and preventive actions to reduce production downtime.
- Support new product and technology introductions, audits, regulatory inspections, and 24/7 plant reliability through rotational on-call coverage.
Requirements
- Doctorate degree; or a master’s degree and 2 years of engineering experience; or a bachelor’s degree and 4 years; or an associate’s degree and 8 years; or a high school diploma/GED and 10 years of engineering experience.
- Bachelor’s degree in Chemical or Mechanical Engineering preferred.
- 6+ years of relevant experience, including 5+ years in biopharmaceutical operations or manufacturing focused on downstream unit operations.
- Direct experience with GMP biopharmaceutical production equipment and systems, including cell culture reactors, centrifugation, chromatography, tangential flow filtration, autoclaves, CIP systems, clean steam, and water for injection.
- Experience with regulated environments and quality systems, including cGMP, OSHA, EPA, change control, non-conformances, CAPA, qualification, and validation.
- Flexibility to support 24/7 operations, occasional after-hours coverage, and approximately 10% domestic or international travel.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual discretionary bonus and stock-based long-term incentives.
- Paid time off plans and company-wide shutdowns twice a year.
- Flexible work models, including remote arrangements where applicable.
- Career development and work-life balance support.
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