Steven Nieves López
Caguas
Summary
MBA Planning and Strategies student with extensive experience in the Pharmaceutical Industry and Medical Device. Currently working as an Environmental Technician. Competent in SOP's, GMP's, and OSHA Regulations. Passionate about delivering quality products. Excellent documentation and inspections skills at the Medical Device Industry.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Environmental Technician
Amgen
Juncos PR
01.2022 - Current
- Worked with site to maintain compliance with applicable environment regulations.
- Performed duties in accordance with applicable standards, policies and regulatory guidelines to promote safe working environment.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Prepare, handle and dispense chemicals for cleaning and sanitization with required PPE.
- Manufacturing Execution Systems(MES)
- Learning Management Systems(LMS)
- Complete all cleaning/sanitization of the manufacturing and technical areas and equipment (outside), as required.
- Coordinate with clients to ensure environmental support activities are performed with no delay to production.
- Communicate with partners, as required, to complete tasks.
- Maintain an up-to-date working inventory for the equipment/supplies.
- Document and review appropriate paperwork, daily logs, files, and work order documentation per Good Documentation Practices. Will also be responsible for documenting and entering data into applicable GMP forms, including electronic batch record.
- Plan and schedule collaboration activities with production staff to minimize impact to production activities.
- All work must be completed in accordance with Code of Federal Regulations(CFR's), cGMPs, SOPs, and Amgen policies.
- Ability to work in an environment where cleaning products are used (i.e., bleach, isopropyl, process NPD, sporicidal, and other disinfectants)
- Participate in a detailed training program in order to develop one's knowledge in the cleaning and other areas of the plant.
- Prepare, handle and dispense chemicals for cleaning and sanitization with required PPE.
- Certified in Germicide Preparation and Sanitization.
- Assisted with data management for regulatory and operational reporting.
Process Technician
Merck
Las Piedras
03.2021 - 07.2022
- Complied with safety rules and standards to maximize efficiencies while reducing accidents.
- Performed preventive maintenance on equipment during scheduled downtime.
- Performed electrical and mechanical troubleshooting on equipment.
- Performed maintenance on machinery and escalated major malfunctions to Mechanical Team for immediate assistance.
- Collaborated with packaging technicians to determine product changeovers and equipment maintenance needs.
- Primarily responsible for manufacturing of controlled oral solid dose products according to approved Master Batch Records
- Responsible for the set-up, operation and cleaning a tablet presses and bulk accountability throughout manufacturing processes.
- Identify and report quality issues Must be in compliance at all times by following batch records, SOP's and all company policies
- Perform all in-process testing and inspections as required by the Master Batch Record (i.e. weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.
- Forklift certified, Safety Data Sheet, HMI systems, FETTE compacting, INFINITY Q.A Sampling, METTLER TOLEDO Balances & Scales, Calculators, SAP/ MES(PAS-X) transactions (Material transfer, Take Out)LMS, Fette Compression Bilayer.
- Determined maintenance needs and completed smooth repairs and efficient preventive actions.
Associate Manufacturing Process Technician Leader
Amgen
Juncos
09.2018 - 03.2021
- Visually inspected devices for defects and placed defective items into reject bin.
- Applied blank labels to devices, packaged and sealed items before sending for quality review(Shipper boxes, Vials, Syringes, Medical Devices.
- Maintained supply inventory by checking stock to determine inventory level.
- Analyze root causes of production issues and develop corrective actions.
- Documents production by completing forms, reports, logs, record of equipment and batches.
- Train and guide team members.(Serialization Process).
- Lead operators to achieve common goals.
- Operating automated industry equipment
- Inspection of Lyophilized products
- Updating job knowledge by participating in trainings opportunities.
- Handled supply inventory by checking stock and ordering new items when needed.
- Working protocols and validations as a team with engineers, mechanics, quality associates and managers for the implementation of new products, and procedures.
- Working protocols and validations of Serialization Processes Recipes for different products.
- Qualifications(Autolabe, Plunger Rod, IMA, Accrapply Conveyors, Serialization Processes, Remote Station, Print Advisor, Printers Zebra, Sampling, Metter Toledo, Closure Labelers, Pre-Line, Handling Rejects, Inspections, Combination Products, Cartoner, Inprocess Checks, Reconciliation, Inventory).
Assembler Technician Lead
Ortho Clinical Diagnostics
Raritan
01.2018 - 06.2018
- Reviewed project specifications and drawings prior to assembling complex components to better understand assignments and expected deadlines.
- Trained new team members by relaying information on company procedures and safety requirements.
- Took on additional job duties during unexpected backlog, resulting in meeting project target date.
- Handled troubleshooting tasks and used repair methods to immediately rectify assembly line issues.
- Inspected finished products for quality and adherence to customer specifications.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Reviewed inventory to eliminate unnecessary expenses and provide optimal stock levels.
Education
MBA - Planning and Strategy
National University College
Bayamon06.2023
Bachelor of Arts - Criminal Justice
Interamerican University of PR
San Juan06.2017
Skills
- Electronic Batch Record(EBR)
- Worksite safety
- Product Reconciliation
- Serialization Processes
- Formulation
- Time reduction strategies
- Production targets
- SAP
- LMS
- Testing protocols
- Data reporting
- Planning and Coordination
Certification
EHS for Packaging(Amgen)
EHS for Outsourced Cleaning and Sanitization Technician
EHS for Lockout/Tagout-Affected Level
Operators of Electric Motor Hand Truck (Forklifts Class III) EHS for AML-01 Inspection Associates
EHS General Requirements for Out of Scope Contractors
Basic Microbiology Training
Combination Product Certification
Handling of Ejects and Rejects
Formulation
Germicide Preparation
Labeling Equipments
Languages
Spanish
Native language
English
Proficient
C2
Timeline
Environmental Technician
Amgen
01.2022 - Current
Process Technician
Merck
03.2021 - 07.2022
Associate Manufacturing Process Technician Leader
Amgen
09.2018 - 03.2021
Assembler Technician Lead
Ortho Clinical Diagnostics
01.2018 - 06.2018
MBA - Planning and Strategy
National University College
Bachelor of Arts - Criminal Justice
Interamerican University of PR
Similar Profiles
Eraya MoralesEraya Morales
Senior Specialty Representative/Dermatology at AMGENSenior Specialty Representative/Dermatology at AMGEN
Dane FlandersDane Flanders
Manufacturing Associate at AmgenManufacturing Associate at Amgen
Micah HefnerMicah Hefner
Senior Manufacturing Processing Tech/Training Assistant at AmgenSenior Manufacturing Processing Tech/Training Assistant at Amgen