Validation Engineer II
Job Location:
Milford, CT - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
The Validation Engineer II provides validation support for manufacturing and facility-related activities throughout the organization. The Validation Engineer II is responsible for general validation duties including validation of facilities utilities equipment mapping of cold rooms and of stability chambers and support of Safety and Continuous Improvement efforts.
Key Responsibilities:
- Provide validation support to Manufacturing and Facilities
- Create Validation documentation including FATs SATs IQs OQs PQs URDs
- Create and maintain Engineering documentation in support of validation projects including ETOPs and Engineering Drawings
- Develop and execute validation protocols
- Work with multi-department teams to coordinate and perform validation activities
- Lead validation deviation investigations
- Assist during the design evaluation and risk assessment of new computer systems equipment facilities utilities processes and cleaning
- Assist during customer audits
- Participating in periodic review of validated systems equipment facilities processes and cleaning
- Performance and documentation of mapping studies for temperature-controlled storage and stability systems
- Participate in Safety and Continuous Improvement efforts to improve safety efficiency and reduce cost
Required Skills/Abilities:
- Bachelor of Science (BS) degree (Engineering preferred)
- Minimum of four (4) years of validation manufacturing or process engineering experience
- Knowledge of pharmaceutical unit operations general mechanical/electrical engineering concepts process and equipment design and an understanding of GMP regulations.
The annualized salary range for this role is $80725.00 - $98660.00.
Required Experience:
IC
About Company
Nordea is a leading Nordic universal bank – we are a strong and personal financial partner with financial solutions that best meet your needs so you can achieve your goals and realise your dreams.
