12 дней назад
Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday-Friday)
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Описание вакансии
Текст:
TL;DR
Manufacturing Systems Engineer: Automation - DeltaV (Swing Shift Monday-Friday) (DeltaV/GMP biopharmaceutical manufacturing): Developing and maintaining Emerson DeltaV process control systems for a new drug substance manufacturing plant with an accent on process automation, validation, data integrity, and commissioning. Focus on advanced troubleshooting, vendor FAT, automation installation verification, change controls, deviations, and integrating manufacturing equipment and field instrumentation.
Location: Holly Springs, North Carolina, United States. On-site role supporting a drug substance manufacturing plant. Swing shift: 3:00 PM–11:00 PM, Monday–Friday, with rotational on-call support.
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses.
What you will do
- Develop and maintain Emerson DeltaV distributed control system solutions for GMP drug substance manufacturing operations.
- Collaborate with capital project stakeholders and end users to translate process requirements into automation solutions.
- Support computerized systems validation, data integrity assessments, commissioning, qualification, and automation installation verification.
- Support vendor factory acceptance testing, troubleshooting, incident investigations, root cause analysis, change controls, CAPAs, and deviations.
- Prepare and maintain engineering, maintenance, SOP, and cGMP documentation.
- Drive continuous improvement in process automation reliability, safety, efficiency, operational workflows, and sustainability.
Requirements
- High school diploma/GED with 8 years of engineering experience; or associate degree with 6 years; or bachelor's degree with 2 years; or master's degree.
- Experience with process control engineering, automation system design, programming, installation, and lifecycle management in GMP biopharmaceutical manufacturing.
- Experience with Emerson DeltaV DCS, advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus.
- Ability to interpret and apply GAMP and GMP requirements, including 21 CFR Part 11, ASTM 2500, S88, and S95.
- Strong technical writing and communication skills, with the ability to work independently and cross-functionally.
Nice to have
- Degree in electrical engineering, computer science, chemical engineering, biotechnology engineering, or a related field.
- Experience with biopharmaceutical process equipment such as bioreactors, chromatography, filtration, CIP/SIP, clean utilities, and OEM automation software.
Culture & Benefits
- Collaborative, innovative, science-based work environment.
- Employee benefits may include retirement and savings contributions, medical, dental, vision, life and disability insurance, and flexible spending accounts.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time off plans and biannual company-wide shutdowns.
- Flexible work models may be available where applicable.
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