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Validation Engineer II
Accepting applicationsNitto Avecia · Milford, MA
Full-Time Mid aiarmateganrf
Posted
6d ago
Category
Test
Experience
Mid
Country
United States
About This Opportunity
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 $80,725.00 - $98,660.00.
Show more Show less
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 $80,725.00 - $98,660.00.
Show more Show less