Validation Specialist

N&CS Consulting Group Inc.; Aibonito (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

N&CS Consulting Group Inc. seeks a Validation Specialist for an on-site contract role based in Aibonito.

You will plan, execute, and document validation protocols for equipment, processes, and computerized systems in regulated life sciences environments. You will review validation documentation, perform test executions, analyze data, and work with engineering, manufacturing, and quality teams to ensure alignment with regulatory standards.

Qualifications

• Experience developing, executing, and documenting validation protocols.
• Experience in validation activities: qualification, performance verification, and monitoring.
• Knowledge of Quality Control practices supporting testing and data review.
• Background in Quality Assurance with audits/inspections.
• Expertise in validation principles in pharma/biotech/biologics/medical devices.
• Familiarity with FDA, EMA and GxP/ISO guidelines.
• Ability to interpret technical documentation and write clear reports.
• Bachelor's degree or equivalent experience in engineering/life sciences.
• Strong organizational skills and on-site task management.

Responsibilities

• Plan, execute, and document validation protocols for equipment, processes, and computer systems.
• Review and draft validation documentation and perform test executions.
• Analyze data and collaborate with engineering, manufacturing, and quality teams.
• Identify gaps and recommend corrective actions.
• Contribute to continuous improvement initiatives for validation and quality systems.

Skills

Computer System Validation

Process Validation

Quality Control

Quality Assurance

Regulatory guidelines

GxP

Documentation writing

Cross-functional collaboration

Report writing

On-site multitasking

Education

Bachelor's degree in engineering or life sciences

Job description

Company Description

N&CS Consulting Group Inc. is a full-service validation and regulatory compliance provider for the pharmaceutical, biotechnology, biologics, and medical device industries. The team consists of experienced professionals who deliver projects on time and within budget, using practical validation approaches and strong customer service. The company focuses on understanding each client’s unique needs, defining clear project requirements, and tailoring services to provide cost-effective solutions. Emphasis is placed on innovative thinking that improves quality, reduces engineering time and design rework, and shortens overall project duration. Candidates can learn more about N&CS Consulting Group Inc. by visiting www.nandcsgroup.com.

Role Description

The Validation Specialist is a contract, on-site role based in Aibonito, responsible for supporting validation and compliance activities in regulated life sciences environments. This role involves planning, executing, and documenting validation protocols for equipment, processes, and computer systems, ensuring alignment with regulatory and company standards. Daily tasks include reviewing and drafting validation documentation, performing test executions, analyzing data, and collaborating with cross-functional teams such as engineering, manufacturing, and quality. The Validation Specialist will also assist in identifying gaps, recommending corrective actions, and contributing to continuous improvement initiatives related to validation and quality systems.

Qualifications

• Strong skills in Computer System Validation, including protocol development, execution, and documentation.
• Experience with Process Validation activities, such as qualification, performance verification, and ongoing monitoring.
• Knowledge of Quality Control practices to support testing, data review, and verification of validated systems and processes.
• Background in Quality Assurance, including compliance oversight and support for audits and inspections.
• Demonstrated expertise in Validation principles within pharmaceutical, biotechnology, biologics, or medical device settings.
• Familiarity with FDA, EMA, and other relevant regulatory guidelines and industry standards (e.g., GxP, ISO).
• Ability to interpret technical documentation, write clear reports, and communicate effectively with cross-functional teams.
• Bachelor’s degree in engineering, life sciences, or a related field, or equivalent relevant experience.
• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and deadlines on site.