Validation Specialist

Pinnaql • Guaynabo, PR

10d

About The Position

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

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level