Laboratory Operations Technician III - Documentation

ANSR is hiring for one of its clients.

About ANSR MedTech:

Who We Are:

ANSR MedTech Capability Center is a new global innovation hub being established in India for a Fortune 100 Fastest-Growing Company in the MedTech sector. Built in partnership with ANSR, the center draws on ANSRs proven experience in establishing and scaling high-performance Global Capability Centers (GCCs) for leading global enterprises.

ANSR MedTech center brings together world-class engineering, product, and technology talent to build next-generation healthcare platforms and solutions that power global operations.

Our Vision:

To build a next-generation MedTech capability center that powers global healthcare innovation.

We envision:

• High-impact innovation hubs shaping global product and technology roadmaps
• Centers that go beyond support functions to drive core engineering and platform development
• Sustainable, scalable ecosystems that nurture world-class MedTech talent
• Capability centers that directly influence patient outcomes worldwide
• At its core, the ANSR MedTech Capability Center is about enabling innovation that touches lives at scale.

Job Summary:

As Laboratory Operations Technician III, you will be responsible for supporting the engineering teams in creating comprehensive documentation for lab equipment. This role serves as the primary resource for engineering staff, offering guidance on tool management processes, documentation, and equipment procurement. Key responsibilities include organizing and maintaining equipment files within the Product Lifecycle Management (PLM) system, ensuring accuracy and completeness of Tool Change Orders (TCO) and maintenance records. The specialist collaborates with QA and Design Control teams to ensure equipment compliance with regulatory and quality standards, assisting with equipment requirements and validation assessments. This position will report to the Laboratory Operations Manager in Bengaluru.

Responsibilities:

• Create comprehensive documentation for equipment used by R&D teams, including user manuals, technical specifications, and safety guidelines
• Serve as the go-to resource for engineering staff, providing guidance on tool management processes, documentation, and equipment procurement
• Organize and maintain equipment files within the PLM system for existing equipment. Ensure accuracy and completeness by revising existing equipment files, including TCO and maintenance records.
• Collaborate with QA and Design Control to ensure equipment compliance with regulatory and quality standards assisting with equipment requirements and validation assessments
• Maintain an accurate inventory of tools and equipment, tracking their availability, location, and condition
• Oversee the equipment tracking system, ensuring timely updates and data integrity
• Monitor equipment utilization and identify opportunities for optimization or replacement
• Coordinate equipment training sessions for users, ensuring proper usage and safety protocols
• Performs or supports execution of small repairs as directed
• Performs other duties as necessary

Required Skills and Competencies:

• Self-starter, detail-oriented, and effective verbal/written communicator
• Ethical, responsible, and data-driven decision-making methodology
• Ability to organize work and judge priorities with guidance
• Experience creating technical documentation for complex equipment
• Familiarity with PLM systems (ex. Arena) and document management
• Knowledge of validation processes and regulatory requirements
• Experienced with building relationships with engineering staff and vendors
• Working knowledge of Enterprise Asset Management software (ex. SAP)
• Experienced with GDP (accurate recordkeeping)
• Understanding of procurement and inventory control
• Office software proficiency (Word, Excel) and technical writing capabilities
• Experience in a medical device regulated environment
• Perform preventive maintenance on R&D tools
• Leads established 5S team, advocating for 5S philosophy with extension of Safety
• Able to lift 30 lbs.

Education and Experience:

• Higher Secondary Certificate (or equivalent education) with concentration in engineering and 4+ years working in a laboratory environment or
• Foundational degree with concentration in engineering and 2 years experience working in a laboratory environment