Project Manager Engineer

LOURDES CONKLIN

**** ******** ** *******, ** ****1

TELEPHONE 787-***-****

E-MAIL- **.*******@*****.***

Background Summary

Masters degree in Engineering Management from the Polytechnic University of Puerto Rico

with a GPA of 3.92/4.00. Bachelor degree in Chemical Engineering from the University of

Puerto Rico-Mayaguez Campus with a GPA of 3.63/4.00. Over 8 years of Manufacturing

experience in the biopharmaceutical Industry. Expertise in Environmental Monitoring

SYSTEMS, Staff Management, project management, Process and System owner (operational

and equipments SME). Extensive experience working with Quality Systems such as Electronic

Document Management (Documentum), Trackwise, Change Control (CCMS) and Maximo.

Possesses an extraordinary sense of urgency and ownership. Focused project manager with a

commitment to deliver excellent results. Fluent in English and Spanish.

ACCOMPLISHMENTS

• IMPLEMENTED A NEW AUTOMATED SYSTEM THAT SIMPLIFIED THE 24/7 ENVIRONMENTAL MONITORING DATA EVALUATION PROCESS

OF A COMPLEX ASEPTIC FILLING PLANT COMPOSED MULTIPLE FILLING SUITES SHARING A COMMON STAGING ROOM AND SUPPORT

AREAS RANGING FROM COMPONENT PREPARATION TO FORMULATION OF PARENTERAL BIOLOGICS.

• MANAGED THE PLANT ENVIRONMENTAL MONITORING SYSTEM UPGRADE PROJECT AND ASSOCIATED CHANGE CONTROL DOCUMENTS

THROUGH AN AGGRESSIVE BUT SUCCESSFUL IMPLEMENTATION SCHEDULE.

• CREATED A NEW PROCEDURE TO DOCUMENT AND INVESTIGATE THE ENVIRONMENTAL SYSTEM ALARMS, WHICH IMPROVED THE

QUALITY OF THE INVESTIGATIONS AND SIGNIFICANTLY REDUCED THE ERRORS COMMONLY FOUND IN THIS TYPE OF INVESTIGATIONS

80%.

BY

• SUCCESSFUL SUPERVISON OF MANUFACTURING ASSOCIATES, BUILT TEAM MORALE AND TEAM WORK BY SETTING EXPECTATIONS,

LEADING BY EXAMPLE AND PROVIDING LEADERSHIP AND EXPERTISE AT ALL TIMES.

• AS THE AREA SUPERVISOR, IMPLEMENTED A SHIFT CHANGE FORM TO PROMOTE AND IMPROVE THE COMMUNICATION OF RELEVANT

INFORMATION BETWEEN ALL SHIFTS.

• PARTICIPATED AS SME IN REGULATORY INSPECTIONS FROM THE FDA, EMEA, JAPAN, CANADA AND CORPORATE

ACHIEVING “0” OBSERVATIONS.

• LEAD INVESTIGATOR FOR DEVIATIONS WITH PRODUCT AND/OR PROCESS IMPACT, ENVIRONMENTAL EXCURSIONS AND EQUIPMENT

ISSUES. INVESTIGATIONS WERE CONSISTENTLY PRAISED BY TOP MANAGEMENT AS VERY WELL DOCUMENTED, ACCURATE AND SELF

SUSTAINABLE.

• AS LEAD INVESTIGATOR ACHIEVED A “0” IMPACT TO LOT RELEASE BY CLOSING PRODUCT DEVIATIONS ON TIME.

• IMPLEMENTED CAPAS TO ADDRESS ROOT CAUSE IDENTIFIED AS PART OF THE INVESTIGATION PROCESS.

EXPERIENCE

ALCON 2011 2013

TO

SCIENTIST V, DECEMBER 2011 TO JUNE 2013

DSM MATERIAL FORMULATIONS- JOHNS CREEK, GA

RESPONSIBLE FOR FORMULATIONS SCHEDULE AND MATERIALS INVENTORY.

RESPONSIBLE TO INVESTIGATE PROCESS DEVIATIONS TO DETERMINE THE ROOT CAUSE OF THE FORMULATION AREA DEVIATIONS

AND IDENTIFY THE CORRECTIVE ACTIONS TO AVOID THE RECURRENCE OF THE DEVIATIONS.

RESPONSIBLE FOR SOP REVISIONS AND CHANGE CONTROL MANAGEMENT THROUGH LOTUS NOTES.

SAP SUPER USER FOR FORMULATION DEPARTMENT.

5S FORMULATION AREA LEAD.

MEMBER OF THE SPILL RESPONSE TEAM.

RESPONSIBLE FOR THE CONTINUOS IMPROVEMENT OF AREA INCLUDING WORK LAYOUT, EQUIPMENTS, SYSTEMS AND

DOCUMENTATION THROUGH THE USE OF PROCESS EXCELLENCE TOOLS LIKE CONTINUOUS FLOW, FIVE S, KANBAN AND

STANDARIZED WORK .

AMGEN MANUFACTURING LIMITED 2003 TO 2011

MANUFACTURING SPECIALIST, DECEMBER 2010 TO MAY 2011

MANUFACTURING SUPPORT DEPARTMENT- JUNCOS, PR

LEAD INVESTIGATOR FOR PRODUCT, PROCESS AND EQUIPMENT RELATED DEVIATIONS.

RESPONSIBLE TO INVESTIGATE PROCESS DEVIATIONS TO DETERMINE THE ROOT CAUSE OF THE DEVIATION AND IDENTIFY THE

CORRECTIVE ACTIONS TO AVOID THE RECURRENCE OF THE DEVIATION USING TOOLS LIKE ROOT CAUSE ANALYSIS, KEPNER TREGOE

CAUSAL FACTOR.

AND

RESPONSIBLE FOR THE IMPLEMENTATION OF THE PROCESS IMPROVEMENTS IDENTIFIED DURING THE INVESTIGATIONS .

INVESTIGATION SME DURING REGULATORY INSPECTIONS.

PRESENT INVESTIGATION OUTCOMES AND FINDINGS TO TOP MANAGEMENT.

MANUFACTURING SPECIALIST, MARCH 2005 TO DECEMBER 2010

ENVIROMENTAL MONITORING SYSTEM DEPARTMENT- JUNCOS, PR

PERFORM AS THE AREA SUBJECT MATTER EXPERT

DIRECT SUPERVISION OF THE SECOND AND THIRD SHIFT EMS STAFF FROM 2006-2007

PERFORM NON CONFORMANCE INVESTIGATIONS (CLASS 1 AND 2)

REVISE AREA PROCEDURES TO IMPROVE AND STANDARIZETHE PROCESS

AREA DOCUMENTS OWNER AND AUTHOR

2

PROJECT MANAGER FOR THE EMS MANUFACTURING LEG OF LARGE PROJECTS SUCH AS THE FILL & FINISH EMS UPGRADE

PROJECT AND THE NEW VIA LINE EMS

SYSTEM OWNER OF THE EMS EQUIPMENTS (VIABLE AND NON-VIABLE MONITORING EQUIPMENTS)

ASSOCIATE ENGINEER, AUGUST 2003 TO MARCH 2005

VIAL FILLING DEPARTMENT- JUNCOS, PR

ENVIRONMENTAL MONITORING SYSTEM (EMS)

PERFORM NONVIABLE ENVIRONMENTAL MONITORING OF THE MANUFACTURING AREAS. VERIFY AND DOCUMENT ANY SITUATION

24 HOURS REPORTS. INVESTIGATE AND DOCUMENT THE EMS EVENT ALARM LOGS. GENERATE

OBSERVED IN ROOMS ON THE EMS

WORK ORDERS WHEN ANY UNUSUAL SITUATION WITH EQUPMENTS OR SYSTEMS IS OBSERVED. COMPLETE THE INVESTIGATION OF

VIABLE MONITORING (ROUTINE, NON PRODUCT RELATED) NONCONFORMANCES. PERFORM NONVIABLE MONITORING DURING

REQUALIFICATION PROCESS AFTER SHUTDOWN ACTIVITIES. PERFORM CONDITIONAL RELEASE REPORTS AFTER ACTIVITIES IN

MANUFACTURING AREAS.

•

Education

POLYTECHNIC UNIVERSITY OF PUERTO RICO - SAN JUAN 2006-2008

ENGINEERING MANAGEMENT- MANUFACTURING MANAGEMENT

MASTERS IN ENGINEERING DEGREE, GPA 3.92/4.00

UNIVERSITY OF PUERTO RICO-MAYAGÜEZ CAMPUS 1998-2003

CHEMICAL ENGINEERING

BACHELOR’S DEGREE. GPA 3.63/4.00. MAJOR GPA 3.78/4.00 GRADUATION DATE JUNE 2003

CERTIFICATE OF ENVIRONMENTAL ENGINEERING

ENGINEER IN TRAINING LICENSE (EIT)

SKILLS

SOFTWARE: MS WORD, MS EXCEL, MS POWER POINT, MS PROJECT, AUTO CAD.

PROGRAMMING: C++, ALLEN BRADLEY PROGRAMMABLE LOGIC CONTROLLERS (PLC)

INDUSTRIAL: CGMP, GOOD DOCUMENTATION PRACTICES

SYSTEMS: MAXIMO, TRACKWISE, CHANGE CONTROL, EDMQ (ELECTRONIC DOCUMENT MANAGEMENT), SAP

TRAINING

Kepner Tregoe

Project Management

Root Cause Analysis

Investigational Skills

Technical Writing

Six Sigma

Leadership

SAP

Hazwoper

Process Based Leadership (PBL)

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