David Mercando Email & Phone Number

Portland, Oregon, United States

Atlanta, Georgia, United States

Medical device company launching vaccine products using micro-needle technology.

Columbia, MD

Greater Atlanta Area

Reported directly to the Vice President of MTS (Manufacturing Technical Support), Validation, and Engineering. Led four departments, Engineering, EH&S, Facilities, and Maintenance with expense budget of $900K and total budget of $2.2M. Ensured cross functional collaboration with all other departments on site.

Norcross, Georgia

Led the Validation department supporting efforts to qualify and validate equipment, methods, and processes for Operations and Labs. Managed resources and equipment expense budget of $1M. Completed gap assessment of all validation documents against corporate and regulatory requirements.

Danbury, CT

Supported the launch of a new product, responsible for both process & cleaning validation activities, process optimization, deviation investigations, continued process verification & change control.

Summit, NJ

Managed a team of engineers & technical specialists, provided support to Merck's manufacturing facilities & external parties. Responsible for non-sterile Oral Solid Dosage technology transfers, process optimizations, investigations and impact assessments on product changes.

Summit, NJ

Process Team Lead for global projects involving technology transfer, equipment and process optimization, validation, and cGMP compliance. I provided technical support for a project involving a legacy product found to have an unacceptable degradant profile. My support kept ~40 existing drug products (DP) on the market, worldwide, without any disruption to.

Kenilworth, NJ

Responsible for compliance activities established to support commitments made to the FDA as part of the consent decree. All FDA 483s related to the critical utilities were resolved and completed on time. I managed capital expansion projects, prepared RFPs, requirement specifications, and fostered business relationships with E&C companies and third-party.

Worked at the R& D technology CenterSupported operations, programming and development work for all reasearch projects conducted at the chemical development area pilot plant.

Bscheme, Chemical Engineering, 3.8 - Highest Honors

Activities and Societies: Tau Beta Pi

Bscs, Chemistry, 2.9

Activities and Societies: ACS Student affiliate - Treasurer