Maintenance Manufacturing

Juan S. Cruz

PROFESSIONAL EXPERIENCE

May ***4 - May 2015

Therapeutic Proteins International, LLC

Chicago, Illinois

Process Engineer II, Parental Fill Finish Department

Responsible for designing and implementing manufacturing processes,

equipment, and plants (from pilot to fully operational) to achieve the

production goals of the organization.

1. Participate in the design, building, FAT, SAT, IQ, IOQ, PQ, and PPQ of

all facility utility systems (Reverse Osmosis System, WFI, Pure Steam

Generator, Clean Compress Air)

2. Lead the implementation of the all fill finish Equipment's such as

Syringe Filler, Vial Filler, Part Washer and autoclave.

3. Responsible in the development of Site Acceptance Test Protocols for

filling lines and support IOQ, PQ, and PPQ execution.

4. Responsible for process characterization activities of new equipment's

and provide solutions of technical process issues as they relate to

product/equipment quality and reliability.

5. Responsible for create new procedure for Preventative Maintenance,

SOP's, Calibration Schedule for all new equipment's of fill finish and

utilities.

6. Support process characterization of Compounding activities and provide

solutions of technical process issues as they relate to

product/equipment quality and reliability

7. Assist FMEA to improve quality, system performance and reliability of

the design.

1. Generates, evaluates and closes change control documentation assuring

the validation and compliance state of the equipment.

2. Subject Matter Expert in filling, isolator technology and auxiliary

process equipment's for fill and finish manufacturing facility.

May 2012- May 2014

Pfizer Pharmaceuticals, LLC

Vega Baja, Puerto Rico

Packaging Maintenance Technologist, Engineering Department

Work with Reliability and Maintenance engineers to learn and implement

techniques to continuously improve packaging equipment reliability and

efficiency.

1. Provide overall daily production support including corrective and

preventive maintenance, troubleshooting, and equipment installations,

modifications and qualifications.

2. Planning activities during shutdown and reduce the Work orders in

backlog.

3. Increase OEE(overall equipment effectiveness)trough improved equipment

reliability.

4. Perform and recommended predictive and preventive maintenance tasks

5. Participate in equipment failure investigations to determine root

causes and propose solutions.

6. Specify critical spare parts and propose min/max levels

7. Assist in equipment and facilities upgrade projects, equipment FAT's

and validation execution

8. SME(subject matter expert) in packaging technologies.

Jan 2006 - Feb 2008 Amgen Ltd,

Juncos, Puerto Rico

Fill Finish Technician, Project Engineering Department

Assigned as a Fill finish Technician, responsible for the start up,

validation execution and process improvement initiatives for new and

existing Amgen Aseptic Areas manufacturing equipment.

1. Coordinate new Fill and Finish equipment start up activities such as:

equipment installation, equipment mechanical set-up; SOP reviews,

Validation execution, calibration and preventive maintenance.

2. Coordinate and review activities in conjunction with the Project

Manager to meet projects milestones as scheduled.

3. Provide Technical assistance to the Manufacturing personnel to ensure

equipment performance.

4. Support Mechanical interventions to existing Manufacturing equipment

5. Lead Mechanic Team to support the automation of a Syringe filling

line. This initiative represented a significant cost reduction

approximately 50%.

Sep1998 - Jan 2006 Pfizer Pharmaceuticals, Inc.

Barceloneta, Puerto Rico

Lead Mechanic, Engineering Department

Assigned, as a Lead Mechanic, supporting the coordination and execution of

start up, installation and repair activities to ensure equipment

performance.

1. Responsible of equipment assembly, disassembly, set up, and repair

2. Coordinate and execute Preventive Maintenance, and instrument

calibrations to ensure proper performance and regulatory compliance.

3. Support New Aylward machine start up activities such as: installation,

mechanical set up, and SOP review.

4. Provide Technical assistance to the Manufacturing personnel.

5. Review of Maintenance SOP's to ensure compliance with site practices

and standards.

6. Monitor tooling condition to ensure maximum equipment efficiencies

maintained

7. Support process improvements initiatives.

Jan 1996 - Sep 1998 Bristol Myers Squibb,

Ltd

Barceloneta, Puerto Rico

Industrial Mechanic, Sterile Manufacturing Area

Assigned as a Mechanic, responsible of the mechanical start up,

installation and repair activities of manufacturing equipment in sterile

area.

8. Responsible for assembly & mechanical set up of Manufacturing

equipment such as: Vial washer, Filling machine, Capper and Labeler.

9. Responsible of executing the Preventive and Corrective Maintenance of

the equipment listed above.

10. Maintain, troubleshoot and repair all aseptic equipment and related

local utilities

Jun 1995 - Jan 1996 Ortho McNeil,

Dorado, Puerto Rico

Manufacturing Operator, Oral Solid Dosage Manufacturing Area

Assigned as an Operator, responsible for the operation of OSD Production

equipment assuring production schedules and product Quality Attributes.

11. Responsible of the operation of the Granulator (Glatt).

12. Skilled on Weighing, and Mixing processes.

13. Review of SOP's to assure compliance with site manufacturing standards

and practices.

CAREER SKILLS AND KNOWLEDGE

1. Refrigeration, hydraulic technologic, & welding.

2. Certified in Motoman Robotics (Yaskawa)

1. Programming software's such as: PLC, Solidwork, Matlab, Simulink,

ANSYS and BASICX

2. Equipment validation.

1. Coordination and organizing.

1. PC proficiency in Windows XP, Microsoft Office Software

2. Fully trained on CGMP's and Safety Processes

1. Responsible, adaptable and dynamic person, self motivated team

worker and high level of desire to learn

1. Excellent interpersonal and communication skills

1. Bilingual (Spanish/English)

EDUCATION

Associate Degree in Mechanical Engineering, 1996

"Instituto Tecnol gico y Vocacional de Manat "

Graduated Cum Laude

BS Degree in Mechanical Engineering, 2013

"Universidad Interamericana de Puerto Rico"

Graduated Cum Laude

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