Lead Senior Automation Specialist, Molecular Systems Resume Marlborough, MA - Hire IT People

SUMMARY

Technical Operations ManagerAnticipate and Prevent Roadblocks, Improving Operations and Component Quality
Leverage experience as technical lead to drive compliance for FDA requirements, standards, and policies, minimizing impact to timelines, safety, and cost. Specialized training in all phases of medical device manufacturing. Recognized for ability to build and lead cohesive technical teams and liaise wif senior leadership, promoting effective GMP practices. Excellent supervisory and technical problem - solving skills.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Confidential, Marlborough, MA

Lead Senior Automation Specialist, Molecular Systems

Responsibilities:

Investigated and resolved non-conforming processes and materials, minimizing machine down time and component defects.
Resolved all automated equipment failures, resulting in high efficiency manufacturing processes.
Performed engineering studies and testing of assembled components as lead investigator wif NCR and CAPA investigations, developing corrective action plan for process failures.
Designed fixtures for stand-alone units for testing of assembled components for LIAT Analyzer.

Confidential ., Shrewsbury, ma

Senior Automation Technician

Responsibilities:

Trained operation staff of 30+ operators and supervisors on automation equipment.
Supported medical device manufacturing and process validations for FDA regulated commercial components. GMP part 820, CE, UL, ISO 13485 & 9000.

Confidential, Los Gatos, CA

Technical Operation Manager

Responsibilities:

Managed technical team servicing equipment in 58 locations nationally, totaling over 500 automated machines. Held approval authority on all aspects of equipment maintenance, team travel, parts acquisition, vendor deployment, and operator training, technical team expense reporting.
Organized equipment installations, scheduling 25 field service technicians and employees nationally for maximum efficiency, minimizing costly down time.
Implemented new work order program “Smartware”, resulting in improved technician performance, machine maintenance, and GDP practices / preventive maintenance scheduling.
Reduced overall operational costs 25% by installing and validating new-to-company compact disc packaging equipment which automated a manual process and improved quality.

Sr. Mechanical Equipment

Confidential

Responsibilities:

Serviced automated manufacturing equipment and oversaw operations of drug packaging machines.
Manufactured, assembled, developed, and tested robotic equipment used in Department of Defense applications.
Manufactured, assembled, developed and tested 3 axis robotic platforms used in plasma screen manufacturing.