Responsible for site Engineering, EHS&S, Facilities, and Maintenance. Develop and execute capital plan.

Manage all site tissue and surgical tool manufacturing and packaging operations

Managed Change Control, Training, Documentation Systems, Receiving Inspection, Post Sterile Inspection and Batch Record Review teams

Rotational management development program consisting of three 8-month assignments in different functions within US/PR plants.Rotation 1: Aibonito, Puerto Rico - Automation/Operational ExcellenceRotation 2: North Cove, North Carolina - RemediationRotation 3: Bloomington, Indiana - Operational Excellence

- Managed 10 direct reports- Responsible for all production equipment, utilities, and facilities maintenance activities across a 2 shift operation

- Provided quality support for manufacturing- Reviewed and approved equipment and test method validation activities- Performed deviation investigations- Developed and validated new test methods

- Provided operations input on design of new sterile formulation/filling facility and equipment- Developed operational readiness plan for commercial operations in the new facility

- Managed team of four (4) direct reports- Standardized visual inspection sampling plans and defect classifications across the site- Streamlined escalation processes

- Supported aseptic processing deviations - Performed remediation of five on-site biological quality laboratories - Functioned as site CA/PA coordinator

- Validated and implemented 21 CFR Part 11 compliant product hold database; managed cross-functional team including Validation, IT, Production, Remediation, and Manufacturing Quality- Performed room qualification of manufacturing areas; managed all aspects of the project including engineering, qualification, and implementation- Provided technical support during external, internal, and customer audits including one-on-one interaction with auditors

- Managed cGMP-related capital projects, performing all aspects of projects including writing proposals, obtaining funding, requesting bids from suppliers/contractors, coordinating orders with purchasing department, organizing required validation, overseeing installation, updating/creating technical drawings and SOPs, etc.- Completed multiple high compliance-risk deviations with impact to final product