Principal Engineer TSMS Validation

Role Summary

We are seeking a highly experienced Principal Engineer to lead and execute validation activities for our Global TSMS (Technical Systems Management System) initiatives.

Responsibilities

• Validation Leadership: Lead the development, execution, and review of validation strategies, plans, protocols, and reports for complex TSMS projects, ensuring adherence to regulatory requirements.
• Technical Expertise: Provide expert technical guidance on validation methodologies, data integrity principles, GxP regulations, and industry best practices related to computerized systems, automation, and manufacturing process controls.
• Project Management: Manage validation deliverables across multiple projects, collaborating with cross-functional teams including IT, manufacturing, quality assurance, engineering, and external vendors to ensure timely and effective project completion.
• Risk Management: Develop and implement risk-based validation approaches, identifying potential risks to system functionality, data integrity, and compliance, and proposing effective mitigation strategies.
• System Lifecycle Management: Contribute to the full lifecycle management of TSMS, from initial design and development through implementation, maintenance, and decommissioning, ensuring continuous validation status.
• Documentation and Compliance: Ensure all validation documentation is accurate, complete, auditable, and compliant with regulatory expectations and company policies. Participate in regulatory inspections and internal audits as a subject matter expert.
• Continuous Improvement: Proactively identify opportunities for process improvement within TSMS validation, driving efficiency and effectiveness in our validation practices.
• Mentorship and Training: Mentor engineers and provide training on validation principles and company procedures.

Qualifications

• Education: Bachelor's degree (e.g., Chemical, Electrical, Computer Science), Computer Science, or a related scientific discipline.
• Experience: Minimum of 5 years focused on sterilization or cleaning validation.
• Technical Skills: Strong understanding of manufacturing processes and control systems (e.g., Pharma suite, Maximo,).
• Leadership And Communication: Proven leadership skills with the ability to influence and guide cross-functional teams. Excellent written and verbal communication skills, capable of effectively presenting complex technical information to diverse audiences. Strong problem-solving and analytical abilities with a keen attention to detail.

Skills

• Experience with various validation tools and methodologies.
• Proficiency in authoring and reviewing complex validation documentation.

Education

• Bachelor's degree in a related field (as listed in Qualifications).

Additional Requirements