Project Engineer

EXPERIENCE

Over nine (*) years experience in pharmaceutical industry on validation

process, computer system and equipment qualifications for FDA regulated

industry and cGMP corporate regulations. Skilled in the technology

transfer for new products for packaging transfers and new business

initiatives. Trained and experienced with hands-on involvements in

preparation and execution of validation protocols and summary reports for

pharmaceutical process and equipment qualification. Experience includes

Packaging Lines (bottles and blister) as well as the development of

validation test techniques, technology transfer and project management.

Timely and responsible in the leadership of assignments, ready to handle

new challenges and perform to the maximum of capabilities. Excellent

communication skills and interpersonal relations.

Norwich Pharmaceuticals, Inc, Norwich NY

Product Development and Technical Services - Packaging Engineer (2009-

current)

. Coordinate and implement Packaging Process Continuous Improvement.

Project management of new packaging process from new business initiatives.

. Defining new packaging equipment and change parts for new and current

business initiatives as well as define packaging components for new

products configurations.

. Contacted suppliers for new equipment, tooling and/or change parts and

materials information required for new product transfers for the packaging

lines equipments and specifications.

. Develop, execute and review protocols for Qualifications and Validations;

IQ/OQs, Process Validations and reports for bottles packaging lines.

. Review protocol documentation and executions.

Mentor Technical Group, Caguas PR

Regulatory and Compliance Validation Specialist / Validation Team Lead

(2003 - 2009)

. Worked as Consultant for various pharmaceutical companies like Pfizer

(Packaging Technical Services/Packaging Process Improver); Mylan Inc.

(Validation Specialist), Wyeth (Validation Packaging Technology); McNeil

Consumer & Specialty Pharmaceuticals (Validation Team Leader); Schering-

Plough Products (Sr. Validation Specialist) and Lilly Del Caribe

(Validation Specialist and Quality Assurance Reviewer).

. Responsible of design, planning, coordination and execution of validation

and qualification protocols for equipment and processes for packaging,

computer and manufacturing areas and assure project completion.

. Worked on granulation, compression and coating processes as well as

packaging processes for solid dose as well for Fermentation and

Purification areas for the Biotechnology industry.

. Prepare reviews and execute Computer System Validation (CSV) protocols,

Validation Plan, URS, Traceability Matrix, Commissioning Qualifications,

IQ/OQs, PQs, FATs, SATs and reports for bottles and thermoformer/blister

packaging lines.

EDUCATION

BS, Industrial Engineer

UPR, Mayag ez, PR

YEARS IN THE INDUSTRY: 9 years

PROFESSIONAL

AFFILIATIONS/MEMBERSHIPS

Society of Women Engineers

Student Chapter, Vice President

and former Secretary

Society of Hispanic

Professional Engineers

PROFESSIONAL DEVELOPMENT /

TRAININGS

Six Sigma Tools

Process Excellence

Yellow Belt Training

Lean Manufacturing

cGMP's

SOP's

OSHA

Developed and provided cGMPs

and Good Documentation

Practices (GDP) Trainings

Module to peers

ACHIEVMENTS AND AWARDS

2004 Star Award provided by

Lilly Del Caribe and Fluor

Daniel for the New Bulk

Humalog( Facility Project.

SKILLS

Team member oriented.

Ability to handle simultaneous

projects.

Self-starter, responsible,

well-organized, excellent

interpersonal relations.

Bilingual, Spanish and English

with basic knowledge of French.

PC Skills

Knowledge in Windows; Microsoft

Office (Word, Power Point,

Excel); MS Project 2000, basic

C++, Minitab; MathCAD, AutoCAD,

FactoryCad.

EXPERIENCE (CONTINUED)

Mentor Technical Group, Caguas PR

Regulatory and Compliance Validation Specialist / Validation Team Lead (2003 -

current)

Contacted suppliers for new equipment, tooling and change parts required for new

product transfers for the packaging lines equipments.

Performed process development, registration, and validation studies for solid

dosage in pharmaceutical manufacturing/packaging.

Coordinated all qualification and validation activities as a validation team

leader. Lead tasks in the transfer of technology of new products.

Prepared and executed Addendum protocols IOPQ and Reports to modifications

performed to the HVAC Control System to the Apogee Computer System.

Reviewed and approved contractors/consultants qualification protocols and

execution, technical reports and deviations or events.

Participate in Trainings to established procedures, offer trainings and exhort

team member involvement activities to Mentor personnel.

Audits of compliance and regulatory issues within the company.

Audited on module vendors execution documentation protocols to ensure compliance

with project quality standards and cGMP requirements.

Perform P&ID drawing walk-downs and revisions.

Generated and review SOPs and offered trainings.

In charge of supervising and reviewing team documents preparation and execution

activities as team lead and responsible for on the job Mentor personnel

resources and project schedule.

McNeil Consumer & Specialty Pharmaceuticals, Las Piedras, PR

Project / Validation Coordinator (2001-2003)

Completed a Green Belt project to reduce the Cleaning Changeover times for the

Compression Area.

Worked with the Packaging department performing time studies, special projects,

process improvement and validations of existing / new equipment and new

packaging codes.

Responsible for the tracking of equipments maintenance and calibrations for the

validation / revalidation projects in the packaging area.

Coordinated, Prepared, Executed and Completed Change Controls, Packaging System

Validations and Packaging Line Trials for new product development on Blister and

Bottle Lines.

Lead Label Verification System Project, as the Project Validation Leader, the

position duties were to coordinate, review and supervise three (3) contractors'

documentation and execution CSV activities (IQ/OQ/PQ) for the carton and leaflet

barcode scanner.

Spice on the Fly Project Leader. Coordinate and supervised installation and

validation process by a three (3) contractors. Responsible of purchasing spare

and change parts.

Packaging Business Unit Leader. Coordinated and facilitated biweekly meetings

between all the departments, which give service to the area, and the management

of the area.

In charge of supervising COOP Program Engineering Students in how to manage

project and validation activities.

Sensormatic Electronic Corp.

Engineering Technician (2000-2001)

Rotate in production areas performing time studies, production sampling, line

balancing, workstation and ergonomic analysis.

Participated in the analysis of established time standards for future updates.

Verified implementation cost of ergonomic concepts and provide recommendations

for workspace reorganization.

Redesigned facility area leading to a 15% increase in workspace, 10% in capacity

and 10% in productivity.

VANESSA E. RIVERA VEGA

Packaging Engineer

30 Midland Dr Apt W2 Norwich, NY, 13815 / 787-***-**** /

*********@*****.***

Contact this candidate