Process Validation Engineer-Operations Engineering

We are looking for a Process Validation Engineer to join our Operations Engineering team and play a key role in ensuring the quality, compliance, and reliability of our manufacturing processes and equipment within a global medical device environment.

In this role, you will lead and support validation and risk management activities across internal and external operations, helping ensure compliance with FDA and ISO requirements while driving continuous improvement initiatives.
You will be responsible for managing validation programs, maintaining risk management documentation, supporting audits, and collaborating closely with cross-functional teams to ensure high standards across systems, products, and processes.

This position requires a strong combination of technical expertise, analytical thinking, organizational skills, and the ability to manage multiple priorities in a fast-paced and highly regulated environment.

Success in this role means becoming a trusted subject matter expert for validation and risk-related activities, driving projects forward with a high level of ownership, maintaining strong collaboration with internal and external stakeholders, and ensuring compliance and operational excellence across validation processes.

What you will do:
Lead the creation of high-level test plans, validation assessments, and validation plans, while overseeing execution progress and completion.
Review and approve test methods, validation test plans, and validation results.
Manage validation samples and support validation execution activities across internal and external operations.
Serve as a point of contact for subcontractor test laboratories and support coordination of validation-related activities.
Maintain and regularly update pFMEA documentation and related risk management records.
Identify risks, support mitigation planning, and implement actions to maintain compliance and process reliability.
Support and conduct internal audits according to the annual audit program and report audit findings.
Manage relevant Issues, NCMRs, and CAPAs related to validation and quality activities.
Serve as a Subject Matter Expert (SME) for validation activities during internal and external audits.
Support continuous improvement initiatives related to systems, products, services, and validation processes.
Participate in and support calibration and preventive maintenance programs for measuring devices and test equipment, as needed.