Validation Specialist

Validation & Engineering Group, Inc.; Aibonito (PR); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

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.

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

IQ/OQ/PQ protocols

GMP knowledge

Technical writing

Cross-functional coordination

Risk assessment (FMEA)

Change control

Project coordination

Regulatory awareness

Formation

Bachelor’s degree in Engineering or Life Sciences

Outils

Validation docs

CAPA system

Environmental monitoring

Description du poste

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist

Key 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.

Required 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.

Preferred Qualifications

• Experience supporting medical device manufacturing and quality systems.
• Familiarity with FDA and/or international medical‑device regulatory requirements.
• Experience with validation lifecycle management and periodic requalification programs.
• Experience with electronic quality management or validation management systems.
• Knowledge of process validation, computerised systems validation or equipment automation is a plus.

At Validation & Engineering Group, people always come first. We believe that when you’re empowered to do your best work, bold ideas thrive and real progress happens. This isn’t just a job - it’s an opportunity to make a meaningful difference by shaping the future of health care and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran status or disability status.