Camilo M. Pascual

Address:

**** ******** **** ****

Oviedo, FL 32766

Phone: 305-***-****

E-mail: acxewr@r.postjobfree.com

CAREER SUMMARY

Technical Specialist with 4+ years of professional experience in the pharmaceutical industry, specifically in remediation of GMP quality issues/gaps, process improvements, and establishment of quality systems. Worked under a consent decree for a manufacturer of non-sterile topical oils and creams, managed multiple projects, and assisted in the FDA approval of Tolak cream. I am currently seeking a position in the life sciences industry with a focus on product approvals, quality systems, validation, and/or process engineering.

PROFESSIONAL

EXPERIENCE

Hill Dermaceuticals

Technical Specialist

Sanford, FL

January 2011 – July 2014

Generated a Development report, planned and validated equipment, process, and facility revisions, identified validation gaps, and created and updated associated SOPs for a new cream with a potent compound requiring operator personal protective dress and engineering controls

Established and managed computerized maintenance management system (CMMS)

Developed plant environmental specifications [particulate counts and Temperature/Humidity (T/H)] and computer system requirements for a continuous monitoring system

Presented quality systems to senior management, FDA inspectors during inspections, and third-party auditors, and resolved various FDA 483 and audit observations

Technical Assistant

July 2010 – January 2011

Closed GMP gaps in developing various technical drawings of facility layout, utilities, process equipment, and personnel/material flows

Updated master batch records to facilitate use and review by operators and QA personnel

Prosthetic & Orthotic Associates

Intern

Orlando, FL

Summers 2008/2009

Interacted with patients and prepared vacuum sockets for hip disarticulates and above/below-knee amputees

Modified plaster molds for check sockets, used multiple machines in finishing orthotic facemasks, and assembled electronic hand-held vacuums

LEADERSHIP

Keough Kitchen

Student Owner/Manager

Notre Dame, IN

August 2007 – May 2009

Managed and operated student hall restaurant, which included budgeting, ordering supplies, advertising, hiring, supervising and scheduling employees, payroll, preparing meals, and maintenance

Increased annual profit by 100% from year-to-year by implementing various improvements

EDUCATION

University of Maryland

Master of Engineering in Bioengineering

College Park, MD

May 2016

GPA: 3.87 / 4.00

Class projects: (1) Cost estimation of obtaining FDA marketing approval for a biosimilar, (2) Design of clinical trials and data to support an IDE approval and PMA for an implantable insulin pump

University of Notre Dame

Bachelor of Science in Mechanical Engineering

Notre Dame, IN

January 2011

CERTIFICATION

Engineer Intern (Engineer-In-Training)

SKILLS

Validation: IQ/OQ/PQ for process equipment and utilities (HVAC, compressed air, boiler/steam, and two different purified water systems), Computerized Systems Validations for CMMS and T/H monitoring software, Process Validations for filling, labeling, packaging and bulk holding, Temperature/Humidity mapping studies, and Cleaning Validations

Computer: Microsoft 7-10, Red Hat Linux, Microsoft Office & Visio, FORTRAN, SQL, Matlab, Pro/ENGINEER, CNC Machining, GAGEpack, viewLinc, and AutoCAD 2010

Languages: Conversational Spanish

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