Senior Validation Engineer

Job Title : Senior Validation Engineer

City : Devens

State : MA

JOB DESCRIPTION : Validation

• Generate execute review finalize and approve validation / qualification protocols.
• Manage and update the validation master plan to align with best industry practices.
• Assist and deliver amendments to the qualification(s) to ensure qualification compliance within deadlines.
• Provide validation / qualification support to quality assurance during audits and during deviation investigations.
• Utilize computerized asset management system for managing validation / qualification schedules.
• Generate operational and maintenance SOPs FATs URSs FRSs validation protocols and reports.
• Source hire and manage general contractors or other validation engineers.
• Train and mentor the local teams on validation approaches protocols and execution of protocols. Oversee generation and execution of qualification documents by employees outside of the Validation / Engineering department.
• Manage the calibration and maintenance of validation equipment.
• Attend vendor FAT (Factory Acceptance Tests).
• Work with other departments to develop equipment specifications and process system designs.

Project

General

EDUCATION AND EXPERIENCE REQUIREMENT : Requires a Bachelors degree in Chemical Engineering and 3 years of experience in job offered or 3 years of experience in the Related Occupation.

RELATED OCCUPATION :

Validation Engineer or any other job title performing the following job duties :

SALARY RANGE : $96366.00 to $131886.00 / year

JOB TIME : Full Time

#LI-DNI

Required Experience :

Senior IC

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 96366 - 131886