Validation Engineer I

VIVEX BIOLOGICS INC • Miami, FL

just now

About The Position

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.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• 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.

Nice To Haves

• 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.

Responsibilities

• Generate and execute qualification protocols to perform equipment qualifications and process validations.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level