Manufacturing Management

Frank Pérez

787-***-**** *********@*****.***

Summary of Qualifications

Solid professional with strong and vast experience in pharmaceutical, medical devices, consumer goods.

Hands on knowledge, and experience in Manufacturing and Operations: Packaging, Scheduling, Planning Pharmacy, Granulation, Blending, Compression, Seal, Sugar Coating, Polishing, Branding Manufacturing and Packaging processes. Hands on supervisor in global facilities. Experience with QSR, cGMP’S, SOP’s, OSHA, EPA, FDA regulations, ISO, and safety. Expertise in planning, budgeting, inventory, validation, documentation, auditing, and investigation procedures including CAPA. Lean Manufacturing, directed Kaizen and 5S events, Value Stream Map, 7Waste Reduction, Kanban, JIT, TPM, SMED, Poke Yoke, POUS, Visual Management, and Color Code. Six Sigma, SPC, DMAIC, SIPOC, CTQ, FMEA.and Team Building. Creative problem solver with ability to lead, drive growth, resolve conflict, improve morale and consistently exceed established goals and objective. Skilled managing multiple projects and priorities. Computer literacy in Microsoft Office: (word, excel, power point, Outlook), SAP, Kronos, Plateau, ISOTrain, MATT, Groupwise and Internet. Bilingual English and Spanish.

Professional Experience

Pfizer (Wyeth), Guayama, Puerto Rico

Manufacturing Supervisor 2006 – 2009

• Pharmacy, Granulation, Blending, Compression, Seal, Sugar Coating, Polishing, Branding Manufacturing and Packaging Areas Portfolio of Products (Advil Regular, Advil PM, Advil Cold & Sinus, Gel Caps, Allergy Sinus, Axid, Liquid Gels and New Products)

• Experienced Supervisor with computer monitored/controlled manufacturing processes in Pharmaceuticals through MES and Medical Devices through MATT.

• Experience implementing Conformance Standards and GMP regulations

• Ability to work a flexible schedule to include evenings and weekends as needed to resolve production issues

• Directed and executed multi-disciplined assignments including the allocation and utilization of department resources in packaging and manufacturing areas as assigned.

• Analyzed production problems, initiated SAP Investigations, determined the roots causes, and recommended action to be taken to improve the processes, productivity, safety, and budgetary performance; Audited area for safety and Compliance on a daily basis.

• Analyzed and project capabilities/efficiencies and manpower requirements and prepare the daily and weekly work schedules based on the Monthly production plan

• Coordinated and supported product validations. Participate in the design and development of new equipment, material, packages and processes.

• Prepared, implemented and trained personnel on standard operating procedures of product, component and process specifications to comply with regulations and guidelines.

• Developed and supervised 71, manufacturing, packaging and inspection operators.

Achievements

• Led the new product launch of Advil Maximum Strength, 160 lots 2 months ahead of the schedule.

• Developed and implemented line balance to maintain continuous flow in manufacturing (Seal, Coating, Polishing and Branding area)

• Implemented lean manufacturing and process excellence methods

• Developed and led the implementations of documentation plan. Trained and re-certified the mfg operators in cGMP and established metrics to measure the errors, the mfg area improved from 70% to 97%.

• Analyzed and implemented a Generic batch number from Pharmacy to Blending in order to create flexibility in compression area, the productivity in Mfg 1 was increased by 38%.

• Improved and implemented production metrics KPI (Key Performance Indicators) OEE and Line Efficiency in packaging areas increased the productivity 80% to 85% and equipment maximization.

• Improved by 20% the efficiency of the 3rd shift operations by retraining, coaching operators and implementing a new layout of the production area thus saving approximately $150K per year.

Frank Pérez Page 2

Guidant, Dorado, Puerto Rico

Manufacturing Supervisor 2000 – 2006

Rola, DSP, Drugs and Tips Manufacturing Areas

• Responsible for the effective planning, organization, control and supervision of the manufacturing process and the maximization of the manufacturing resources and productivity.

• Change management through support World Class initiatives, facilitation of self-direct work teams, and the identification and implementation of the continuous improvement opportunities. Supervised 43+ production operators ensuring compliance with regulations and company policies.

• Performed corrections and investigations, Action Plan for correctives actions and Preventive Actions (CAPA). Monitor productivity metrics on daily basis.

• Responsible for capacity planning, employee performance management, attendance program, training & development and assertive disciplinary progressive plan. Coordinated drugs (DXA) shipments to Germany.

Achievements

• Completed the DXP drug production for the next 3 years 2 weeks ahead of the schedule.

• Reduced operators DXA Certifications by 6 weeks, saving $3,000. per each mfg operator.

• Reduced the DXA drug thru put by 7 days.

• January 2005 FDA & June 2005 BSI Audits – Zero Observations.

• Kaizen Final Pack – reduce thru put 3 days to 1.8 days $200000.00.

• Quarterly Symbol Employee.

Brady Manufacturing Area

• Supervised 60+ production operators, ensuring compliance with regulations and company policies.

• Prepared, implemented and trained personnel on standard operating procedures of product, components and process specifications complying with regulations and guidelines.

• Developed the value stream map for Brady production line, analyzed and implemented the improvements to increase the productivity, UPP and eliminate the non-values activities.

• Standardized the workstations to facilitate the tasks and implement the color code for product family.

• Supervised and coordinated shift operations. Managed department budget to achieve financial goals.

• Performed investigations on CAN, NC, FDN, PTM and MI Yields. Investigate and report all accident in a timely fashion.

Achievements

• Implemented Lean manufacturing tools such as 5s, Value Stream Map, 7 Waste Reduction, JIT, Kaizen, Kanban, Visual Management, and Color Code.

• Created a rework process for 1624 units and saved $324,800.

• Reduced the Overtime 10.00% to 0.36%, Monthly savings $5000

• Implemented the Heat Sealer machine for the sterile trays pack product. Increased the output productivity by 40%. The manual tray pack process was automated and the ergonomic issue was corrected.

• Reduced the Brady Thru put 2.8 to 1.8 days reduce 50 units in the pipeline $10000.00

• Reduced the Humidity cure time 6 hrs to 2 hrs, Kanban size reduce 40 units $8000.00

• Reduced the absenteeism 6.0% to less than 1%

• Kaizen Gowning Area annual saving $300,000

• Implemented the Visual Bin Component Management system saving $1.4M on inventory levels annually.

• Kaizen Fineline Tray Pack saving $250,000.

Frank Pérez Page 3

Millipore Co., Cidra, Puerto Rico

Process Engineer & Production Supervisor

Mixing & Polymerization Manufacturing Areas 1999 – 2000

• Responsible for mixing and polymerization manufacturing process and mechanical engineering services in the manufacturing and packaging of membrane sterile and non-sterile products.

• Provided direct technical support, evaluate & execute opportunities for improve of current manufacturing process performance.

• Provided support to Quality Department to maintain cGMP, and compliance.

• Train the manufacturing operator on standard operating procedures.

• Supervised five production operators and 3 mechanics engaged in the manufacturing of membrane for filter products, ensuring compliance with regulations and company policies.

• Provided preventive, corrective and predictive maintenance jobs to production equipment. Coordinated and facilitated the J machine upgrade.

Achievements

• Increased Yields by 20%.

• The J casting machine was automated PLC increase the productivity 25%.

• The mixing area was complete repaired 2 weeks ahead of the schedule.

Colgate Palmolive, Juncos, Puerto Rico 1996 – 1999

Team Facilitator

Molding, Tufting, Seal & Packaging

• Facilitated the development and empowerment of the teamwork by providing technical and social trainings. (Self-Managed Team Work Philosophy).

• Improved the employee performance providing feedback and counseling. Directed and coordinated all molding, manufacturing, inspection and packaging activities related to the Consumer products family.

• Developed and supervise 85 operators: Molding (6+1Mech.), Tufting (30+5Mech.), Sealing (6+1Mech.), Bogo (5), IWKA (5), Intn’l (7) UBC (4), Bulk (7), Quality Inspectors (3) and Material Handler (3) Group Leader (2) operators.

• Performed adequate line balancing of manufacturing operations to maximization the resources.

• Provided support to Quality Dept in process validation and experiment manufacturing orders. Coordinated and supervised cycle count inventory.

Achievements

• Reduced the cycle time Injection Molding by 28% (17 sec).

• Increased the output IWKA 800 to 1200 box increase the packaging capacity 50%.

• Completed the Gripem’s and Star Wars new product launch 1 month ahead of schedule.

• Increased the Wave Production toothbrush from 8000 to 10000 units (25%) $24000.00 per month.

Education

University of Turabo, Gurabo, Puerto Rico

Master Degree in Human Resources (Completed May 2010)

University of Turabo, Gurabo, Puerto Rico

Master Degree in Management and Material Control (In Progress)

University of Puerto Rico, Mayagüez Campus

Bachelor of Science in Mechanical Engineering

Frank Pérez Page 4

Trainings and Certifications

• (CRM) Cardiac Rhythm Management Training (Brady arrhythmias, Tachyarrhythmia’s, Heart Failure)

• Time Management Training

• Ergonomic & Human Factor Training

• TQM, JIT, MRP, World Class

• Leadership Development

• Targeted Selection

• Injection Molding Training Engel’s 300 Tons

• Train the Trainer

• Energy & Conservation Auditing Course

• Design, Evaluation & Interpersonal Relation Seminars

• Solid Dosages Training & Certification

• Project Management

• Lean Manufacturing (5s, Kaizen, Kanban, TPM, 7Waste, VSM, POUS, JIT, SMED, Poke Yoke, Visual Mgmt)

• QSR, CGMP and ISO Regulations

• Six Sigma Introductory

• Statistical Process Control SPC

• Water Purification System

• Self-Managed Team Work Philosophy

• Continuous Improvement Methodology

• CIAPR - E.I.T.

• Selection & Recruitment, Labor Legislation, Supervision & EHS certification

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