Senior Validation & CSV Engineer

This person is responsible for leading validation teams' efforts for systems and processes to ensure compliance with industry standards and regulatory requirements. This role involves leading validation activities, developing validation strategies, executing test plans, analyzing data, and providing technical expertise to cross-functional teams. The ideal candidate will have extensive experience in validation leadership, methodologies, strong analytical skills, and a proactive approach to problem-solving.

Key Responsibilities:

Provide full technical oversight, actively leading the overall validation & qualification of equipment and processes in collaboration with colleagues in Añasco.
Lead, support, guide, and coordinate validation activities with team members to ensure adequate resource assignment, task prioritization, and progress monitoring according to schedule.
Collaborate with Manufacturing Engineering, Operations, Quality Assurance, and Regulatory teams to define validation requirements.
Support Regulatory Affairs with submissions to regulatory bodies and associated inquiries.
Actively guide the team in the transition from semi-manual to automated validation methodologies, including the development of necessary validation and CSV documentation.
Develop and implement validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.
Implement and coordinate the change control process, promoting timely approval of all supporting documentation.
Ensure compliance with industry regulations such as FDA, GMP, or other relevant standards.
Design and execute test plans, analyze results, and document findings in technical reports.
Provide technical leadership in troubleshooting validation-related issues and drive continuous improvement initiatives.
Maintain detailed documentation of validation activities and ensure traceability of validation data.
Mentor junior engineers and team members in validation methodologies and best practices.
Collaborate with subject matter experts to trace the defined user requirement specifications (URS) throughout the equipment qualification process (e.g., FDS, DDS, FAT/SAT, and IQ/OQ/PQ).
Use risk analysis tools and generate and close discrepancies, deviations, and failure investigations.
Raise and manage change requests, driving the change from its inception through the change control process to closure.
Train personnel on Good Documentation Practices (GDP) and validation requirements.

Required Qualifications & Experience:

Bachelor’s or master’s degree in engineering, Science, or a related field.
Minimum of 5-7 years of experience in validation engineering, preferably in medical devices.
Strong understanding of validation principles, regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 13485, GMP), and statistical analysis tools.
Hands-on experience with test methodologies, software validation, and process validation.
Strong analytical skills and problem-solving abilities.
Excellent communication and project management skills. International collaboration experience is desired.
Ability to work independently and lead validation efforts in a fast-paced environment.
Certification in validation, Six Sigma, or quality management systems (e.g., ASQ, CQE).
Expert in Microsoft applications (e.g., Word, Excel, PowerPoint Etc.).Experience with automation validation and software tools such as ETQ reliance‘s change management system, QUMAS quality and compliance management systems.
Prior experience and familiarity with Johnson & Johnson day-to-day applications and procedures within the medical device field of expertise is a distinct advantage.

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