Project Manager

OMAR MELENDEZ MURIENTE, PE

**** ******* ***** ** ********, GA 30066 787-***-**** *********@*****.***

SUMMARY OF QUALIFICATIONS

Professional Mechanical Engineer with more than fifteen years of experience in the Pharmaceutical Industry. Manage cross

functional teams for capital projects overseeing budget and resources, maintaining customers’ expectations. Responsible to

drive innovation, reduce cost and schedule while ensuring project deliverables. Foster best practices, benchmarking and lessons

learned initiatives within all capital project implementation. Capable of generating all require documentation in line with the

company’s policies and procedures in a GMP environment. Accountable for new technology implementation, process equipment

installations, upgrade to the infrastructure, energy savings projects, plant expansions, internal project communication and client

interfaces, develop maintenance and metrology programs. Ability to create and promote employees involvement maintaining a

team environment. Proactive, organize, capable to work independently and able demonstrate problem solving skills related to

complex challenges. Computer literate in Microsoft (Word, Excel, PowerPoint, Outlook), AutoCad, SAP and Internet. Fully

bilingual English and Spanish.

PROFESSIONAL EXPERIENCE

OSMOTICA PHARMACEUTICALS, MARIETTA, GEORGIA

ENGINEERING & FACILITIES MANAGER 2012 – PRESENT

Provide supervision, technical direction, administrative management and leadership in the maintenance and engineering

areas.

Direct and actively manage all maintenance needs for the site, building, support utilities, process equipment, and

analytical areas. Ensure activities are governed by approved SOP’s.

Assure maintenance and metrology programs are in full compliance with regulatory expectations and industry best

practices.

Development and application of reliability engineering, root-cause analysis and troubleshooting of equipment and

processes.

Responsible for project management for small and large capital projects in a GMP environment. Prepare project scopes,

charters, PIDs, I/O lists, URS, IQ/OQ/PQ among others project documentation.

PFIZER, GUAYAMA, PUERTO RICO-SOLID DOSE

ENGINEERING LEAD 2010 – 2012

Ensures that all equipment and facilities are in compliance, running efficiently and safely to ensure maximum

equipment performance and reliability.

Provide technical support to Operations, supporting the implementation of new technology.

Develop, implement and oversee predictive, preventive and corrective maintenance programs.

Elaborate department budget and assist in the analysis of operating expenses, focusing on related labor, materials,

allocations and contract services.

Evaluate and manage workload to determine the need of outside contractors and/or resources, assuring that suppliers

provide effective service which is in compliance with SOPs, GMPs, and PMOs.

SENIOR PROJECT ENGINEER 2001 – 2010

Initiate, develop, plan and evaluate multiple capital projects from concept phase to final closeout. Perform required

functions to provide engineering support, management, execution and commissioning and qualifications of large to

medium projects or initiatives.

Assemble and lead engineering teams utilizing in house and external resources. Manage and supports large-

scale/complex projects that have significant impact on company and divisional goals.

Develop solutions to complex problems, which require the regular use of ingenuity and creativity

Managed a budget of $150 MM and the construction activities for the erection of a green field state of the art Analytical

Laboratoy Building.

PHARMACEUTICAL RESEARCH AND DEVELOPMENT EXPANSION

Project Manager for Wyeth $48.0 MM twin Pharmaceutical Development Center (PDC), facilities for Guayama, PR and

Newbridge, Ireland sites. Responsible to maintain strict liaison with Newbridge site in order to assure corporate

guidelines, standards, mission, goals, project scope and charter were met as per agreed from the conceptual design.

Managed a budget of $4.6 MM for the expansion of the Pharmaceutical Development Center. New solid dose

manufacturing facility enhancement, built new production suites, install new equipment (Bin Blenders, Tablet press,

Roller Compactor, Bin washer, Isolator etc.) and the respective utilities upgrades.

Omar Meléndez Muriente, PE 2

WYETH, CAROLINA, PUERTO RICO-PARENTERALS

SENIOR PROJECT ENGINEER

Prepare projects schedules and cost estimates; develop scope of work, construction management, inspections, start-up

and qualification.

Managed project lifecycle, including justification for capital appropriations, developing progress reports, review of shop

drawings, submittals, protocols and expedite project’s deliverables.

Implement process improvements and cost savings opportunities.

Create Standard Operating Procedures for Project Management aligned with Company’s conformance standards.

Responsible for the leadership and supervision of the Project Management Division.

PROJECT MANAGER INTERIM 2003 – 2004

Responsible for the Engineering Department Project Management Division, supervision of employees, management of

multiple projects, administration of project phases, management of capital budget and Engineering Service Request

Program.

PACKAGING HIGH SPEED TRAY LINE

Managed a budget of $4.0 MM for the acquisition and installation of a complete end of the line-automated system,

which considered; labeler, tray packer, shrink wrapper, case & carton palletizer and inspection system.

All project activities were implemented in parallel with packaging area operations, minimizing impact and/or disturbance

to the area.

Lead a multidisciplinary team for the development of a transition plan in order to minimize impact on the operation,

were the line operations was upgraded from a semi-automatic to a fully automated process.

ASEPTIC MANUFACTURING AREA HVAC UPGRADE

Managed a budget of $2.2 MM for the retrofit of the entire aseptic core (approximately 4.0K sq ft.), this area was

enhanced from an individual terminal HEPA filter to a plenum type system. Project implementation schedule of 40 days

(shutdown activity).

Due to the limited access to the aseptic core area creative judgment and value engineering were critical.

Pursue and accomplish zero accidents on the field, even though this project was part of a mayor site shutdown where

approximately 200 contractors participated.

PROCESS EQUIPMENT INSTALLATION

Managed a budget of $6.5 MM for the installation of two vial washer and two depyrogenation tunnels with a project

implementation schedule of 40 days (shutdown activity).

Extensive planning was required to partially execute project activities prior to shutdown in order to minimize unforeseen

events and assure project completion.

Engineering drawings weren’t accurate and alternate solutions were provided maintaining project schedule.

IVAX LABORATORIES, CIDRA, PUERTO RICO

ENGINEERING DEPARTMENT, FACILITIES ENGINEER 2000 – 2001

J. ALIFONSO & ASSOCIATES, BARCELONETA, PUERTO RICO

SEARLE LTD 1999 – 2000

MECHANICAL ENGINEER

CMA ARCHITECTS & ENGINEERS, SAN JUAN, PUERTO RICO

DESIGN ENGINEER - MECHANICAL ENGINEERING DEPARTMENT 1998 – 1999

EDUCATION

Bachelor in Science in Mechanical Engineering

University of Puerto Rico, Mayagüez Campus

Lic. # 17104 PE, OSHA 30 hrs Certified PMI Certification In process

Contact this candidate