Validation Specialist

Jc Automation Corp

Puerto Rico
Permanente
Tiempo completo

Hace 2 días

About Company:JC Automation Corp. (JCA) was founded in **** with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It's mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.About the Role:The Validation Specialist plays a critical role in ensuring that manufacturing processes, systems, and equipment meet all regulatory and quality standards before full-scale production. This position is responsible for designing, executing, and documenting validation protocols to confirm that processes consistently produce products that meet predetermined specifications. The specialist collaborates closely with cross-functional teams including quality assurance, engineering, and production to identify areas for process improvement and to implement effective validation strategies. By leveraging expertise in process optimization and digital transformation, the Validation Specialist helps drive efficiency and compliance within the manufacturing environment. Ultimately, this role ensures that all validation activities support the company's commitment to product quality, safety, and regulatory compliance across the United States manufacturing sites.Minimum Qualifications:

Bachelor's degree in Engineering, Life Sciences, or a related technical field.
3+ years of experience in validation within a manufacturing environment, preferably in regulated industries.
Strong knowledge of validation principles, regulatory requirements (e.g., FDA, ISO), and quality systems.
Proven experience in project management and process documentation.
Excellent communication skills and ability to work collaboratively in cross-functional teams.

Preferred Qualifications:

Certification in validation or quality assurance (e.g., ASQ Certified Quality Engineer, Certified Validation Professional).
Experience with digital transformation initiatives and automation tools in manufacturing validation.
Advanced training in process optimization methodologies such as Lean Six Sigma.
Familiarity with manufacturing execution systems (MES) and electronic documentation management systems.
Leadership experience in managing validation teams or projects.

Responsibilities:

Develop, review, and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.
Collaborate with engineering, quality assurance, and production teams to identify validation requirements and ensure compliance with industry regulations and company standards.
Analyze validation data and prepare comprehensive reports documenting results, deviations, and corrective actions.
Lead continuous process improvement initiatives by identifying inefficiencies and recommending optimized validation approaches leveraging digital tools and automation.
Manage multiple validation projects simultaneously, ensuring timely completion while maintaining high standards of accuracy and documentation.
Communicate effectively with stakeholders to provide updates on validation status, risks, and mitigation plans.
Train and mentor junior staff on validation procedures and best practices to build team capability.

Skills:In this role, decision making is essential for evaluating validation data and determining appropriate corrective actions to maintain compliance and quality. Leadership skills are utilized to guide cross-functional teams and mentor junior colleagues, fostering a culture of continuous improvement. Time management is critical to balance multiple validation projects and meet strict regulatory deadlines without compromising accuracy. Strong communication skills enable clear and effective interaction with stakeholders at all levels, ensuring transparency and alignment on validation activities. Attention to detail and expertise in process improvement and optimization are applied daily to enhance validation protocols and support digital transformation efforts that increase efficiency and reduce risk within manufacturing operations.

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