Senior Laboratory Technician

• Collaborate with Engineering, QA, Facilities, and external service providers to support lab operations.
• Lead and execute laboratory remediation programs aligned with cGxP standards (ISO 13485, GLP, FDA QSR, GDP).
• Author and approve SOPs, work instructions, and technical documentation in line with GDP and Data Integrity standards.
• Own CAPA and deviation processes, ensuring timely resolution and robust documentation.
• Deliver training programs and mentor staff on compliant lab practices, equipment use, and safety.
• Develop risk-based strategies for equipment qualification, calibration, and lifecycle management.
• Implement lean processes for inventory and procurement, and lead 6S and EHS initiatives.

We are seeking an experienced laboratory professional to lead strategic remediation and compliance initiatives in a regulated medical device environment. This role is critical to ensuring laboratory infrastructure, equipment, documentation, and practices meet global regulatory standards.

• Proven track record in leading remediation and compliance initiatives.
• Minimum 10 years of experience in a regulated medical device or pharmaceutical laboratory.
• Strong knowledge of cGMP, GLP, GDP, ISO 13485, and EHS standards.
• Bachelor’s or Master’s degree in Engineering, Science, or related technical discipline.
• Excellent communication, organizational, and stakeholder management skills.
• Proficiency with Blue Mountain software.
• Six Sigma or Lean certification preferred.
• Experience supporting audits and regulatory inspections.