Validation Specialist

Pinnaql, Inc.; Aibonito (PR); Presencial; USD 85 000 - 115 000; Tempo integral

Resumo da oferta

Validation & Engineering Group seeks a Validation Specialist to lead validation activities for medical devices, ensuring IQ/OQ/PQ execution, risk management, and regulatory compliance.

The role requires collaboration across Engineering, Quality, Manufacturing, and Facilities to deliver compliant validation deliverables and maintain ongoing qualification programs.

Qualificações

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Hands-on validation and qualification experience in regulated manufacturing environments.
• Proficient with IQ/OQ/PQ protocols and validation documentation.
• Knowledge of FMEA and risk management methodologies.
• Experience with change control, deviations, CAPA, and calibration processes.
• Experience with facilities, utilities, cleanrooms, and environmental monitoring.
• Strong GMP and regulatory quality system knowledge.
• Excellent technical writing and project coordination skills.
• Ability to lead cross-functional validation activities.

Responsabilidades

• Develop, review, and execute VMPs and validation protocols (IQ, OQ, PQ).
• Validate equipment, facilities, utilities, cleanrooms for device safety and product quality.
• Create and maintain validation documentation with traceability and approvals.
• Define validation roles, training, and competency requirements.
• Maintain inventories; support calibration and qualification programs.
• Coordinate with Engineering, Quality, Manufacturing, Facilities, and Operations.
• Plan resources, downtime, and milestone scheduling.
• Manage change controls, deviations, and CAPAs related to validation.
• Support periodic requalification, data trending, and management review.
• Ensure compliance with medical-device quality and regulatory requirements.

Conhecimentos

IQ/OQ/PQ

FMEA / risk mgmt

Change control / CAPA

Calibration & maintenance

Equipment qualification

GMP knowledge

Technical writing

Cross-functional collaboration

Formação académica

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

Ferramentas

Electronic quality management system

Validation lifecycle management system

Descrição da oferta de emprego

Current job opportunities are posted here as they become available.

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, organizational, 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, computerized 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 healthcare and technology alongside a purpose-driven, supportive team.

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