Validation Engineer – Medical Devices & GMP Compliance

Pinnaql, Inc.; Aibonito (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Validation Specialist to lead validation activities for medical-device related projects. You will develop VMPs, execute IQ/OQ/PQ, and manage risk assessments, change controls, CAPAs, and documentation.

You will collaborate with Engineering, Quality, Manufacturing, and Facilities to ensure timely, compliant validation deliverables. The role requires a engineering or life sciences background and hands-on experience in

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• Experience in validation and qualification within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing environment.
• Hands‑on experience with IQ/OQ/PQ protocols and validation documentation.
• Experience with risk management methodologies, including FMEA.
• Knowledge of change control, deviations, CAPA, calibration, maintenance, and equipment qualification processes.

Responsabilités

• Develop, review, and execute Validation Master Plans (VMPs) and validation protocols, including IQ, OQ, and PQ.
• Validate and qualify equipment, facilities, utilities, cleanrooms, and other systems that may impact medical-device safety and product quality.
• Establish and maintain validation documentation, including protocols, reports, acceptance criteria, traceability, and stakeholder approvals.
• Define and document validation roles, responsibilities, training, and competency requirements.
• Maintain equipment inventories and support calibration, preventive maintenance, and qualification programs.
• Support cleanroom and utility qualification activities, including environmental monitoring and trending.
• Perform and document risk assessments, including FMEA, to identify and mitigate risks associated with equipment, processes, and systems.
• Manage validation-related change controls, deviations, and CAPAs, ensuring appropriate investigation, documentation, and closure.
• Coordinate with Engineering, Quality, Manufacturing, Facilities, Operations, and other stakeholders to ensure validation activities are completed according to project requirements.
• Plan and coordinate resources, equipment availability, and required downtime to meet project milestones and schedules.
• Obtain appropriate stakeholder review and sign-off for validation deliverables.
• Support ongoing validation controls, including periodic requalification, continued monitoring, data trending, and management review.
• Ensure validation activities remain compliant with applicable medical-device quality and regulatory requirements.
• Identify potential compliance gaps and recommend corrective or preventive actions.

Connaissances

Technical writing

Documentation

Project coordination

Cross-functional collaboration

Analytical thinking

Formation

Bachelor’s degree in Engineering, Life Sciences, or related

Description du poste

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Validation Specialist to lead validation activities for medical-device related projects. You will develop VMPs, execute IQ/OQ/PQ, and manage risk assessments, change controls, CAPAs, and documentation.

You will collaborate with Engineering, Quality, Manufacturing, and Facilities to ensure timely, compliant validation deliverables. The role requires a engineering or life sciences background and hands-on experience in