•Manages key client projects. (Currently OEM build projects.) •Coordinates and completes projects on time, within budget and within scope. •Oversees all aspects of projects. Sets deadlines, assigns responsibilities, monitors, and summarizes the progress of the project. •Prepares reports for upper management regarding the status of the project. •Analyzes and coordinates the schedule, timeline, procurement, staffing, and budget of a product or service on a per-project basis. •Responsible for being the main point of contact for the client or customer. •Assists in the design process of calibrated or PM’d instrumentation. •Assists with calibration projects that are separate from project management to utilize my core skills within the industry. •Assists in local troubleshooting at client sites for AES OEM equipment.

• Established new Calibration Business unit within the company• Established & implemented new CMMS (Computerized Maintenance Management System)• Assisted in ISO 9001 17025 Certification• Assisted in Networking & Marketing to win current CQV clients for Calibration• Assisted in Networking & Marketing to win NEW clients for Calibration• Established & managed Field Calibration Team across the nation• Established & managed Field Calibration Technician training program• Established & managed Employee Development Program• Created & Reviewed Quality documents pertaining to Calibration• Assisted CAPA investigations

Project Team - Lonza

Project - New England Bio Labs

Project - Moderna

Project Team - Lonza

During this project I evaluated the calibration program and improved all aspects to become and maintain GMP compliance. This included:*SOP changes*Personnel development throughout the department (organization, time management)*Closing gaps and corrections in calibration documents.*Assisting with Go Live of Blue Mountain.*Review credentials and provide feedback on approved Calibration Suppliers.*Assisting with NCR and CAPA investigations while training personnel to evaluate criticality of events.

• Create and Maintain Calibration Databases• Perform in-house calibrations to reduce Metrology contractor costs. (Lyophilizers, Autoclaves, Depyrogenation Ovens, WFI, Clean Steam, USP, HVAC, USP balances, Scales, Freezers, Stability Chambers.)• Developed an efficient and cost effective Calibration program for all LSNE sites.• Coordinate with Metrology Contractors to ensure calibration of all critical instrumentation is performed according to the schedule and approved SOPs.• Determine calibration specifications for critical instruments.• Review calibration certificates• Maintain Equipment Files• Maintain calibration standards• Assist Validation personnel with equipment qualifications• Gowning Technique • Clean room facility flows• Assist with CAPAs and Deviations• Create and Maintain Calibration SOPs• Develop efficiencies in calibration scheduling and costs.

• Develop, author, and revise quality control documents including test methods and work instructions.• Lead other technicians to execute work for the day/week. Follow up with customer requests, rushes, repairs, and concerns.• Author and review calibration certificates.• Developed an organized environment for efficient workflow based on fundamental 5S principles.• Head on-site equipment calibrations including those requiring clean room gowning and aseptic technique.• Maintain GMP compliance both in house and onsite at all times.• Process control for customer equipment. (Responsible for what stage of qualification every piece of equipment is in to minimize customers’ equipment downtime.)

• Developed an inventory control system for all equipment and parts for easy restocking processes.• Responsible for process control of internal equipment as well as customer equipment.• Responsible for inventory for equipment such as Kaye Validators, IRTDs, Dry Well baths, Digis, RH Sensors, Batteries, etc.• Interfaced with couriers for pick up,(requires knowledge of how and when to ship a piece of fragile equipment at the cheapest price, on the safest route.)• Responsible for electronic calibration entries for all equipment, which requires acute attention to detail and compliance to GDP specifications.• Led the safety committee to bring the Metrology Lab up to date with cGLP. Including exit signs, correct fire extinguishers, MSDS updating, etc.• Transferred all paper based inventory onto the network.

I manufactured Premium Type T and K Thermocouple sets and singles. This includes harnessing, steam slicing, labeling, stripping, tipping, and testing.