Validation Engineer: Medical Devices & GMP Compliance

Veg Group; Aibonito (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States invites a talented Validation Specialist to join our team and help develop, review, and execute validation Master Plans and validation protocols, including IQ, OQ, and PQ.

You will validate and qualify equipment, facilities, utilities, cleanrooms, and related systems while maintaining documentation and approvals. We require hands-on experience with validation documentation, risk assessments (FMEA), and change controls.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• Experience in validation and qualification within the medical device or 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.
• Experience with facilities, utilities, cleanrooms, and environmental monitoring programs.
• Strong GMP knowledge and adherence to quality requirements.
• Strong technical writing, documentation, organizational, and project coordination skills.
• Ability to work collaboratively with cross-functional teams and manage multiple validation activities.

Responsibilities

• Develop, review, and execute Validation Master Plans and validation protocols including IQ, OQ, and PQ.
• Validate and qualify equipment, facilities, utilities, cleanrooms, and related systems.
• Establish and maintain validation documentation with approvals and traceability.
• Define 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 risk assessments, including FMEA, to identify and mitigate risks.
• Manage validation-related change controls, deviations, and CAPAs with proper closure.
• Coordinate with Engineering, Quality, Manufacturing, Facilities, Operations, and stakeholders.
• Plan resources, equipment availability, and downtime to meet milestones.
• Obtain stakeholder review and sign-off for validation deliverables.
• Support ongoing validation controls including periodic requalification and data trending.

Skills

Strong technical writing

Documentation

Project coordination

Cross-functional teamwork

GMP knowledge

FDA/regulatory familiarity

Education

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

Job description

Validation & Engineering Group, Inc. in the United States invites a talented Validation Specialist to join our team and help develop, review, and execute validation Master Plans and validation protocols, including IQ, OQ, and PQ.

You will validate and qualify equipment, facilities, utilities, cleanrooms, and related systems while maintaining documentation and approvals. We require hands-on experience with validation documentation, risk assessments (FMEA), and change controls.