Manager Engineer

Background

Over ** years of experience in medical device and pharmaceutical manufacturing

operations.

Seasoned Manager with over nine years of supervisory experience and in-depth

project management skills.

Experience working in a Consent Decree environment and implementing

remediation projects targeted for manufacturing areas.

Knowledgeable of Lean Concepts and continuous improvement tools. Green Belt

trained.

Deep business acumen and multi-functional experience in manufacturing,

finance, logistics and IT.

Excellent communication skills at all organizational levels.

Experience

2011-Present

Mc Neil, a J&J Company

Las Piedras, PR

Sr. Manufacturing Supervisor

Assist BU manager in delivering planned production volumes in compliance with

GxP, safety standards and all other applying laws and regulations. Develop

tactical manufacturing plans with planning, maintenance, and other service

departments. Act on behalf of Section Manager on her absence. Member of

multidisciplinary team responsible of evaluating deviations and quality

incidents. Review/approve technical protocols, SOP and other regulatory.

Implement manufacturing remediation initiatives as required. Directly

supervise 20+ resources.

Increased production to plan by 10%, delivering +98% in the last 6 months

Increased operator cross-training by 20% and attained 100% compliance with

training curricula

Increased manufacturing batch record review Right First Time by 10%

2008 - 2011 Wesco Integrated Supply Port Washington, NY

Operations Manager- Engineering Stores - PR Region

Manage 30MM Engineering Storerooms operation, for business client (Pfizer PR

region). Provide warehousing and inventory management technical support to US

sites. Re- engineered planning, sourcing, warehouse and inventory management

business processes and established best practices across all sites within the

program. Managed of continuous improvement projects and had full

accountability of key performance indicators. Maintain accuracy of inventory

master data including lead times, min/max and reorder levels. Manage VMI

contracts. Ensure compliance with safety, cGMP regulations and internal

operational standards.

Increased inventory accuracy from 87% to 99%

Implemented cost improvement projects, saving $200 K

1998-2007 AstraZeneca (IPR Pharmaceuticals, Can vanas, PR

Div)

2003 -2007 Sr. IS Project Team Leader

Lead all Software Development Life Cycle stages of IS continuous improvement

projects. Delivered SAP functionality upgrades, Trackwise implementation for

Quality and EHS CAPA management. Managed SAP support package application and

validation protocols among others. Delivered SAP solutions to comply with

Foreign Trade Zone regulatory reporting.

2001-2003 Business Lead

Managed the cross functional project team responsible for the SAP design,

development, and implementation to support procurement, sales, accounts

payable, inventory management and warehouse management. Project Scope

included process re-engineering, business change management, protocol

development, software validation, SOx compliance testing, SOP update and user

training. Overview the design and implementation of change control processes

and procedures.

1998 -2001 Senior Project Analyst

Provide engineering management/financial analysis to monitor and control

operational and capital expenditures of a world-class bulk drug manufacturing

facility, including financial reporting. Developed SOx gap assessment and

implemented corrective and mitigation controls. Developed and monitored an

11MM budget. Performed plant capacity/financial evaluations for new products.

1996-1998 C.R. Bard Las Piedras, PR

Manufacturing Engineer

Support manufacturing operations of implantable cardiovascular medical

devices. Duties include equipment troubleshooting, manufacturing supervision,

work in process and incoming material evaluation and validation activities.

Managed domestic product transfer projects of 100+ vascular prosthesis.

Support Facilities Department during Shut Down maintenance works.

1995-1996 Stryker Corporation Arroyo, PR

Packaging/Manufacturing Engineer

Responsible of packaging related activities to assure product integrity on

sterile medical devices, which include machine/process troubleshooting,

validation of sealing processes and design review for packaging configurations

of new products.

Education

1997-1999 Polytechnic University of Puerto San Juan, PR

Rico

M.E.M., Master in Engineering Management

1989-1994 University of Puerto Rico- R.U.M Mayag ez, PR

B.S.I.E., Bachelor in Sciences of Industrial Engineering; Cum Laude

Docent Experience

2000-2001

Turabo Univeristy

Caguas-PR

Facilitated two Engineering Department Courses: Production Planning (Aug-Dec)

and Workstation Design (Jan-May)

Capabilities

Professional Engineer - License No.15865

AstraZeneca Project Management Framework Certified.

Computer literate. Proficient in the use of MS Office (Word, Excel, Power

Point, Project, Visio, etc.) tools. Knowledgeable SAP user (IM, WM, MM).

Knowledgeable Data Stream user.

Proficient in the management of all software development life cycle (SDLC)

phases, change management assessment and end user training.

Knowledge of regulatory requirements for cGMP, OSHA, EEO, ADA and DOT

Knowledgeable of Lean tools and 5S methodology.

Fully Bilingual Spanish/English

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