3 дня назад
Project Engineer (Pharma)
103 200 - 161 250$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Project Engineer (Pharma): Supporting the design, construction, commissioning, qualification, and manufacturing transfer of capital projects in pharmaceutical, biopharmaceutical, and fine chemicals environments with an accent on process engineering, equipment specification, process safety, and validation. Focus on coordinating multidisciplinary projects, executing FAT/SAT and IQ/OQ/PQ activities, troubleshooting manufacturing processes, and maintaining quality and compliance documentation.
Location: US-CO-Frederick
Salary: $103,200–$161,250 per year, plus eligibility for bonus, stock, and benefits.
Company
provides instruments, services, consumables, applications, and expertise for life science, diagnostic, and applied market laboratories worldwide.
What you will do
- Support the design, construction, commissioning, qualification, and validation of new capital projects and processes.
- Develop user requirement specifications, process designs, equipment and instrumentation specifications, procurement plans, and turnover documentation.
- Coordinate project schedules, budgets, design firms, equipment suppliers, constructors, and multidisciplinary teams.
- Support technical transfer and process scale-up from Chemical Development and Manufacturing Services into manufacturing.
- Participate in process safety activities, including Process Hazard Analysis, Pre-Startup Safety Review, and Process Safety Management compliance.
- Review and execute FAT/SAT and IQ/OQ/PQ validation activities and support change controls, CAPAs, audits, and quality documentation.
Requirements
- Bachelor’s degree in Mechanical, Electrical, Chemical, Biochemical, Manufacturing Engineering, or equivalent education and experience.
- 5 years of experience in the pharmaceutical, biopharmaceutical, and fine chemicals industries.
- 4 years of experience with P&IDs, facility layouts, mass and energy balances, solvent handling, equipment sizing, URSs, SOPs, and process troubleshooting.
- 4 years of process engineering experience and experience supporting projects through design, procurement, installation, commissioning, and qualification.
- Ability to perform responsibilities independently with limited direction.
- Occasional travel may be required; the schedule is full time, day shift, with no stated end date.
Nice to have
- Knowledge of ASME BPE, NFPA 70/NEC, and international fire and building codes.
- Experience with SCADA, PLCs, BAS, and IQ/OQ/PQ validation documentation.
- Ability to use AutoCAD, Revit, and Visio.
Culture & Benefits
- Eligibility for bonus, stock, and benefits.
- Inclusive, merit-based workplace committed to equal employment opportunity and accessibility.
- Occasional travel with a regular day-shift schedule.
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