7 дней назад
Manufacturing Systems Engineer: Automation (Biotech)
105 362 - 142 549$
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Описание вакансии
Текст:
TL;DR
Manufacturing Systems Engineer: Automation (Biotech): Developing and maintaining process automation systems for a GMP drug substance manufacturing plant with an accent on Emerson DeltaV DCS, computerized systems validation, and automation lifecycle management. Focus on integrating control systems, supporting commissioning and qualification, troubleshooting regulated manufacturing operations, and driving improvements in safety, reliability, efficiency, and sustainability.
Location: Holly Springs, North Carolina, United States
Salary: $105,362.60–$142,549.40 per year
Company
is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.
What you will do
- Develop and maintain process control systems on the Emerson DeltaV distributed control system.
- Translate process requirements into automation solutions for a new GMP drug substance manufacturing plant.
- Support computerized systems validation, data integrity assessments, vendor FATs, commissioning, qualification, and automation installation verification.
- Maintain engineering, maintenance, SOP, and cGMP documentation.
- Own change controls, CAPAs, deviations, incident investigations, root-cause analysis, and troubleshooting.
- Support day-to-day plant operations, rotational on-call coverage, capital projects, and continuous improvement initiatives.
Requirements
- High school diploma/GED and 8 years of engineering experience, an associate’s degree and 6 years of engineering experience, a bachelor’s degree and 2 years of engineering experience, or a master’s degree.
- Experience with automation system design, process control engineering, troubleshooting, programming, installation, and lifecycle management.
- Experience with Emerson DeltaV DCS, advanced troubleshooting, and integration using OPC, Foundation Fieldbus, and Profibus.
- Ability to apply GAMP and GMP requirements in a regulated environment, including 21 CFR Part 11, ASTM 2500, S88, and S95.
- Strong technical writing, communication, and cross-functional collaboration skills.
- Role based at the Holly Springs, North Carolina manufacturing site, with rotational on-call support.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Employee benefits may include medical, dental, vision, life, disability, and flexible spending coverage.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives may be available.
- Paid time off plans and biannual company-wide shutdowns.
- Flexible work models, including remote arrangements where applicable.
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