Validation Specialist

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.