Associate Validation Engineer

Job Description

Job Description

Description :

The Associate Validation Engineer is responsible for supporting the company’s equipment and process validation activities. This position is responsible for developing and executing validation protocols and reports, as well as supporting validation projects lead by Senior Engineers. The Associate Validation Engineer is also responsible for evaluating manufacturing process improvements, supporting risk management activities, and providing support with compliance activities as required.

Requirements :

Duties and responsibilities

• Generate and execute qualification protocols to perform equipment qualifications, test methods and process validations. This includes establishing qualification strategy, performance criteria, equipment troubleshooting, coordinate execution, data analysis and reporting to ensure compliance with all internal policies and procedures and external federal, state, and governing body regulations and standards.
• Support the evaluation of engineering systems, of new and existing processes and equipment, to determine validation / verification requirements ensure the company is operating in a state of control.
• Support company’s Master Validation Plan (MVP) including commissioning activities and protocols executions and establishing re-validation criteria.
• Support senior engineers with execution of projects.
• Collaborate with other departments to develop plans, improve, evaluate, and implement engineering systems and processes.
• Use engineering analytical skills to develop and monitor process and equipment metrics to be used for optimization analysis.
• Measure and analyze equipment and processes data to ensure highest product quality and effectiveness of processes.
• Responsible to support company’s change control program to ensure changes are evaluated for risk, validation / verification requirements and are performed in a controlled manner.
• Support compliance activities (CAPA, Nonconformances, Complaints, Planned Deviations, etc.) as necessary.
• Other duties as assigned.

Qualifications

Education Required :

Bachelor’s degree in engineering or a related technical discipline.

Experience Required :

Experience Preferred :

Licenses / Certifications :

Working conditions

Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and / or move objects weighing up to 30 pounds.

Direct reports

This role does not have any direct reports.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

Vivex Biologics, Inc is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and / or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.

Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.