4 дня назад
Sr. Engineer I, Instrumentation & Controls (Biotechnology)
93 000 - 120 750$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Engineer I, Instrumentation & Controls (Biotechnology): Supporting pharmaceutical manufacturing and laboratory analytical instrumentation with an accent on GMP compliance, equipment reliability, calibration, validation, and control systems. Focus on troubleshooting complex instrumentation, leading capital and commissioning projects, implementing control strategies, and defending engineering practices during regulatory inspections.
Location: Research Triangle Park, North Carolina, United States
Salary: $93,000–$120,750 per year
Company
is a mid-sized biotechnology company developing life-changing medicines with a focus on scientific excellence and regulated pharmaceutical operations.
What you will do
- Provide engineering, validation, and troubleshooting support for manufacturing and laboratory analytical instrumentation.
- Author deviations, CAPAs, change controls, risk analyses, and system impact assessments in a GMP environment.
- Support instrument calibration, CMMS scheduling, commissioning, qualification, startup, and facility upgrade activities.
- Lead instrumentation and controls projects from design through implementation, managing scope, schedules, resources, and budgets.
- Configure and troubleshoot DeltaV, PLC, SCADA, DCS, DAS, LIMS, Empower, LabX, and related control platforms.
- Mentor I&C technicians and junior engineers while supporting regulatory inspections and cross-functional improvement initiatives.
Requirements
- Bachelor’s degree in Engineering.
- At least 4 years of relevant engineering experience in pharmaceutical, biotechnology, manufacturing, or other highly regulated environments.
- Strong knowledge of FDA GMP and EMA regulatory requirements.
- Expertise with HPLC, UPLC, pH and conductivity instrumentation, balances, and scales.
- Experience with validation protocols, deviations, CAPAs, change controls, electrical schematics, and instrumentation troubleshooting.
- Ability to support occasional extended shifts or weekend work as business needs require.
Nice to have
- Low-voltage control panel wiring, troubleshooting, and repair experience.
- Facility and utility instrumentation experience.
- Regulatory inspection support, capital project leadership, and instrumentation upgrade experience.
- Experience mentoring technicians and junior engineers.
Culture & Benefits
- Regular employees receive short- and long-term incentive opportunities, including cash bonuses and equity incentives.
- Medical, dental, vision, life, disability, wellness, and fitness reimbursement benefits.
- Paid vacation, company holidays, personal-significance days, sick time, and parental leave.
- 401(k) matching, employee stock purchase plan, and tuition reimbursement of up to $10,000 per year.
- Inclusive workplace focused on collaboration, learning, growth, and employee resource groups.
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