Senior Validation Engineer en None

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 

• Generate and manage project timelines, including proper resourcing for future qualifications. 
• Investigation and resolution of equipment and system problems. 
• Represent the validation/qualification department during safety/quality audits. 
• Assist in the calibration, adjustment, and modification of plant and lab process instrumentation. 
• Manage several projects simultaneously. 

General 

• Perform all of  the foregoing within pharmaceutical/chemical manufacturing industry specifically related to equipment validation on calibration according to GMP standards and internal standard operating procedures. 
• Work safely, injury free, and participate in improving department and site safety performance. 
• Provide technical support to the Maintenance, Production, Lab and Calibration departments. 
• Aid in continuously improving the efficiency and effectiveness of the system. 

EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Bachelor’s 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:

• Led cross-functional teams to develop, optimize, and implement process improvements, ensuring compliance with industry regulations and best practices.
• Developed and executed testing protocols for process equipment, utilities and systems.
• Managed activities for manufacturing processes, ensuring adherence to quality standards and regulatory requirements.
• Conducted root cause analysis and implemented corrective and preventive actions (CAPA) to resolve process deviations and enhance operational efficiency.
• Collaborated with engineering, production, and quality teams to streamline workflows, reduce cycle times, and improve production capacity.
• Utilized Lean Manufacturing and Six Sigma methodologies to optimize processes, improve efficiency, and reduce costs.
• Authored and maintained standard operating procedures (SOPs), work instructions, and technical documentation to support operational and regulatory compliance.
• Monitored and analyzed key process performance indicators, identifying opportunities for continuous improvement.
• Assisted in regulatory inspections and audits by ensuring process documentation and/or validation activities met compliance requirements.
• Implemented data-driven decision-making strategies using statistical tools and analysis to enhance product quality and process reliability.

SALARY RANGE: $96,366.00 to $131,886.00/year

JOB TIME: Full Time

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