Validation Engineer (Process Validation)

Job Description

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.