What are the responsibilities and job description for the Validation Engineer I position at Vivex Biologics?
Description
Job purpose
The Validation Engineer I is responsible to support company’s equipment and process validation activities. This position is responsible for developing and executing validation protocols and reports. The Validation Engineer I is also responsible for evaluating manufacturing process improvements and provide support on compliance investigations and on the risk management assessment.
Duties And Responsibilities
Qualifications
Education Required
Bachelor’s degree in Engineering or a related technical discipline.
Experience Required
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.
Job purpose
The Validation Engineer I is responsible to support company’s equipment and process validation activities. This position is responsible for developing and executing validation protocols and reports. The Validation Engineer I is also responsible for evaluating manufacturing process improvements and provide support on compliance investigations and on the risk management assessment.
Duties And Responsibilities
- Generate and execute qualification protocols to perform equipment qualifications and process validations. This includes establishing performance criteria, equipment troubleshooting, and ensuring compliance with safety and quality standards.
- The evaluation of engineering systems, of new and existing processes and equipment, to 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.
- Collaborate with other departments to evaluate 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.
- Responsible to support company’s change control program to ensure changes to the quality system are evaluated for risk and are performed in a controlled manner.
- Support compliance investigations and recommend corrective and preventive actions.
- Other duties as assigned.
Qualifications
Education Required
Bachelor’s degree in Engineering or a related technical discipline.
Experience Required
- Previous experience as a validation engineer or a similar role.
- Experience in FDA regulated industry such as pharmaceutical, biotechnology, medical devices, or HCT/P manufacturing.
- Strong analytical, planning, critical thinking, troubleshooting, and problem-solving skills.
- Ability to effectively communicate with multidisciplinary teams.
- Excellent technical writing.
- Experience in biopharma manufacturing operations, including cleanroom environments.
- Knowledge of current Good Manufacturing Practices for Biologics, Devices, and Tissues.
- Certified Tissue Banking Specialist (CTBS) certification preferred.
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.