11 дней назад
Validation Engineer (Pharmaceutical Manufacturing)
60 966 - 85 694$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Validation Engineer (Pharmaceutical Manufacturing): Validating and requalifying pharmaceutical manufacturing equipment, systems, and controlled environments with an accent on cGMP compliance, analytical instrumentation, and technical documentation. Focus on executing validation protocols, analyzing qualification data, investigating deviations, and supporting HEPA filter and critical-area airflow testing.
Location: Grand Island, NY, United States; on-site manufacturing and equipment validation work
Salary: $60,966–$85,694 annually
Company
provides pharmaceutical and healthcare products and operates in a regulated manufacturing environment.
What you will do
- Validate and requalify equipment, systems, products, and controlled environments according to SOPs.
- Prepare protocols, coordinate testing, execute studies, analyze data, and prepare final reports for approval.
- Program and operate temperature and humidity dataloggers, thermocouples, and other analytical instruments.
- Perform HEPA filter integrity and velocity testing and support critical-area airflow pattern testing.
- Investigate deviations, support corrective and preventative actions, and contribute to equipment improvement teams.
- Support validation program improvements, change control, and presentations to regulatory agencies when required.
Requirements
- Bachelor’s degree in science, engineering, manufacturing technology, or a related field, or equivalent manufacturing experience.
- 1–3 years of pharmaceutical manufacturing experience.
- Knowledge of cGMPs, industry guidance, and aseptic techniques.
- Ability to write clear technical reports and deviations, accurately record data, and apply basic statistical analysis.
- Proficiency with standard Microsoft Office applications, including Word, Excel, PowerPoint, Project, and Access.
- Effective English communication is required for understanding regulated workplace policies, procedures, training materials, and communications.
Culture & Benefits
- Work in cross-functional, high-performance teams while also handling assignments independently.
- Medical, dental, and vision coverage.
- Life insurance, disability coverage, and a 401(k) with company contribution.
- Wellness program.
- Employment is at-will and subject to applicable federal and state laws.
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