7 дней назад
Validation Engineer II (Biotech)
137 000 - 177 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Validation Engineer II (Biotech): Qualifying and maintaining biotech facility equipment, utilities, instrumentation, and computerized systems in a validated state with an accent on cGMP compliance, risk assessment, and technical documentation. Focus on coordinating CQV campaigns, executing qualification protocols, managing vendors, and resolving validation risks across Engineering, Manufacturing, and Quality Assurance.
Location: Framingham, Massachusetts; 5-day on-site expectation
Salary: $137,000–$177,000 annual base pay, plus performance incentive bonus, equity, and benefits.
Company
is a biotechnology company developing oncolytic immunotherapies to transform cancer treatment through its proprietary RPx platform.
What you will do
- Qualify and maintain facility equipment, utilities, instrumentation, and computerized systems in a validated state.
- Conduct impact and risk assessments and support user requirement specifications.
- Author and execute qualification, validation, and revalidation protocols and reports.
- Coordinate CQV campaign scheduling, execution, documentation review, change controls, and requalification assessments.
- Oversee vendors and contractors performing qualification activities.
- Support investigations, equipment troubleshooting, audits, inspections, and cross-functional validation activities.
Requirements
- Bachelor’s degree in a scientific, engineering, or similar subject; an MSc is preferred.
- At least five years of professional experience in validation, engineering, or operations.
- Experience with GMP utilities and equipment is required.
- At least three years of relevant experience in a cGMP environment is preferred.
- Knowledge of cGMP and GDP requirements, with strong technical writing, communication, and interpersonal skills.
- Ability to work on-site in Framingham five days per week.
Culture & Benefits
- Work in a collaborative, purpose-driven biotechnology environment focused on cancer treatment.
- Medical, dental, and vision insurance.
- 401(k) matching, flexible time off, and paid holidays including a year-end shutdown.
- Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity.
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