Validation Engineer - GMP/Regulated Systems Expert

Validation & Engineering Group, Inc.; Aibonito (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Validation Specialist to lead validation activities across medical devices and regulated environments. You will develop VMPs, execute IQ/OQ/PQ, qualify equipment and facilities, and maintain essential documentation to ensure product quality and compliance.

Collaborate with Engineering, Quality, and Facilities to plan resources, manage schedules, and drive risk-based improvements. Strong GMP knowledge and writing skills are required to succeed.

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.
• Experience working with facilities, utilities, cleanrooms and/or environmental monitoring programs.
• Strong understanding of Good Manufacturing Practices (GMP) and applicable quality requirements.
• Strong technical writing, documentation, organisational and project coordination skills.
• Ability to work collaboratively with cross-functional teams and manage multiple validation activities simultaneously.

Responsibilities

• 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.

Skills

IQ/OQ/PQ protocols

GMP knowledge

Technical writing

Cross-functional coordination

Risk assessment (FMEA)

Change control

Project coordination

Regulatory awareness

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Validation docs

CAPA system

Environmental monitoring

Job description

Validation & Engineering Group, Inc. seeks a Validation Specialist to lead validation activities across medical devices and regulated environments. You will develop VMPs, execute IQ/OQ/PQ, qualify equipment and facilities, and maintain essential documentation to ensure product quality and compliance.

Collaborate with Engineering, Quality, and Facilities to plan resources, manage schedules, and drive risk-based improvements. Strong GMP knowledge and writing skills are required to succeed.