Validation Engineer (Process Validation) - 1815458

Join Our Team as a Validation Engineer Process Development!

Medical Device Industry

Location: North Area, Puerto Rico (Onshore) - 100% Onsite Work

Purpose Statement:

As a Validation Engineer in Process Development, you will play a crucial role in developing and reviewing documentation and procedures. Your expertise will be instrumental in providing automation systems testing and validation to support Process Development and/or Manufacturing Process Engineering.

Key Responsibilities:

• Support process and/or equipment validation activities (IQ, OQ, PQ)
• Conduct process performance qualification activities and develop Master Validation plans for new processes or products.
• Review and develop process validation protocols and reports; provide support during validation activities in collaboration with other functional areas.
• Collaborate with the Process Development team to efficiently qualify new processes; assist in statistical sampling plans and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components.
• Generate equipment documentation, including entries, evaluations, PM, and calibration procedures.
• Define gauges, tools, and equipment for the developed test methods.
• Generate manufacturing instructions for newly developed processes.
• Collaborate cross-functionally with other departments to accomplish Process Development tasks.

Quality System Requirement:

In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

• Assure that appropriate resources (personnel, tools, etc.) are maintained to ensure Quality System compliance and adherence to the Quality Policy.
• Establish and promote a work environment that supports the Quality Policy and Quality System.

Discover a Rewarding Career - Apply Now! #ValidationEngineer #ProcessDevelopment #QualityFirst