Gardy Semidey
Professional with more than ten years of experience in the Pharmaceuticals and Medical Devices Industry
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Sobre mí
Professional more than ten years of experience in the Pharmaceuticals and Medical Devices Industry. Advanced technical skills with experience in the manufacturing and packaging operations. Highly developed working skills. Ability to motivate and supervise the activity of others. Multi task working experience.
Verbal
Communicator.
Conflict
Resolution.
Working Area Problem
Solving. Knowledge of c'GMP. Bilingual (Spanish and English).
Experiencia
MANUFACTURING OPERATOR at JANSSEN (2025-09 – Present)
- RESPONSIBLE FOR OPERATING, MONITORING AND ADJUSTING AUTOMATED MACHINERY IN PRODUCTION LINES WITHIN A REGULATED ENVIRONMENT.
- ENSURING COMPLIANCE WITH QUALITY STANDARDS, SAFETY REGULATIONS, AND GOOD MANUFACTURING PRACTICES (GMP).
- PERFORMING ROUTINE INSPECTIONS, ACCURATE PROCESS DOCUMENTATION, BASIC MECHANICAL TROUBLESHOOTING, AND COLLABORATING WITH MAINTENANCE AND QUALITY TEAMS TO GUARANTEE OPERATIONAL EFFICIENCY AND PRODUCTION CONTINUITY.
- COMMITTED TO CONTINUOUS IMPROVEMENT AND MEETING PRODUCTION GOALS.
MANUFACTURING OPERATOR at MERCK LAS PIEDRAS (2022-10 – 2023-01)
- Execute manufacturing processes in accordance with BMR and SOPs requirements.
- Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time.
- Prepare a room and equipment for line clearance, replace room filters, confirmed verification and calibration of balance/scale and check pressure differential for the rooms.
- Ensure line clearance before initiating manufacturing activities in each area.
- Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
- Wear appropriate PPE as stated in the SOP/BMR before initiating process.
- Able to operate applicable equipment independently as per area of operation.
- Troubleshoot and make appropriate adjustments to equipment to maintain product/BMR specifications.
- Ensure adherence to quality standards during all stages of the manufacturing process.
- Complete manufacturing documents on time, ensuring accuracy and completeness.
- Prepare solution on Likwifier tanks to be used in the process.
- Utilize computer systems, electronic batch records and SAP.
- Collect samples after completion of each batch.
- Perform use of electric/manual hand trucks, drum inverters and bowl inverters.
PRODUCTION OPERATOR/ASSEMBLER at LUTRON SM (2022-09 – 2022-10)
- Assemble and disassemble electrical circuit boards as well as dimmer switches.
- Perform pneumatic welding.
- Perform cleaning procedures and 5s standards.
MFG PROCESS TECHNICIAN at AMGEN (2020-08 – 2022-03)
- Apply experience and judgement to make decisions or resolve issues within standard operating procedures.
- Anticipate problems and recognizes when deviation to procedures occur.
- Perform equipment setup, operation, troubleshoot to meet all standards for safety, quality and efficiency.
- Perform basic troubleshooting to identify potential solutions for mechanical errors, safety issues or general operating inefficiencies within the production process.
- Able to utilize computer systems and electronic batch records.
- Safety Follow standard operating procedures including but not limited to material handling, inspection and packaging. Must follow good manufacturing practices (GMP).
- Maintain a suitable work environment process.
- Manufacturing experience in GMP.
- Utilize computer systems and electronic batch records.
- Excellent attention to detail, good organization, and capable of working independently with minimal supervision.
- Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
- Wear appropriate PPE as stated in the SOP/BMR before initiating process.
- Able to operate applicable equipment independently as per area of operation.
- Troubleshoot and make appropriate adjustments to equipment to maintain product/BMR specifications.
- Ensure adherence to quality standards during all stages of the manufacturing process.
- Complete manufacturing documents on time, ensuring accuracy and completeness.
- Prepare solution on Likwifier tanks to be used in the process.
- Utilize computer systems, electronic batch records and SAP.
- Collect samples after completion of each batch.
- Perform use of electric/manual hand trucks, drum inverters and bowl inverters.
- Ability to read, write and follow written and verbal instructions both in Spanish and English languages.
PACKAGING OPERATOR at GLAXOSMITHKLINE (2019-10 – 2020-07)
- Supply components and materials to the production area.
- Knowledge on the operation and management of the packaging machines.
- GMP record documentation on paper and electronic form.
- Monitoring and inspection of the packaging lines for compliance with area cleaning procedures and 5S standards.
- Perform cleaning activities of critical product contact areas on the production equipment (filler parts) and line cleaning for product changeover.
ASSEMBLER/OPERATOR at INGRAM MICRO MOBILITY (2018-02 – 2018-03)
PACKAGING OPERATOR at BECKTON & DICKINSON (2017-08 – 2018-01)
ASSEMBLER/OPERATOR at UTC AEROSPACE SYSTEMS (2014-05 – 2015-05)
MECHANIC OPERATOR PACKAGING at MCNEILL (2009-09 – 2010-10)
MANUFACTURING OPERATOR at MEDISEARCH (2008-09 – 2009-04)
PACKAGING OPERATOR at PROCTER & GAMBLE (2000-03 – 2001-05)
Educación
ELECTRICIAN DEGREE in Electrical Studies – INSTITUTO DE BANCA Y COMERCIO
