Experience

FITS, LLC

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• MS&T Senior Packaging Technology Specialist

  • Aug 2022 - Present

• Senior CSV Specialist / CSV Compliance

  • Jun 2021 - Present



QRC Group, LLC

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• Senior Validation Engineer

  • Jun 2019 - Jun 2021

  Amgen Juncos CW Senior Engineer • Independently provides and/or directs the characterization of process optimization strategies and/or trouble shooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. • Applied advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. • Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. Bencton Dickinson Juncos Consultant:Preparing Validation Documents and CSV Documents ( Validation Plan, Engineering Studies, IQ, OQ and PQ protocols with all reports) related to the introduction of assembling Line D.Execution of protocols ad preparing completion reports as parts of the validation and qualification activities of the assembling line D.



Johnson & Johnson Consumer McNeil Healthcare LLC.

• QA Validation Specialist IV / Senior Quality Engineer

  • May 2012 - May 2019

  • Responsible for the review and approval of qualification and validation documents, operational procedures and supporting documentation. • Assure compliance with the validation program, while simultaneously balancing business, technical and quality issues and enhancing the validation program.• Partner with QA Validation resources at other JJCI sites to look for harmonization and leverage of best practices. • Ensure adherence to McNeil, J&J and regulatory health authorities’ requirements in addition to the Site Validation Master Plan..• Review and approve documentation related to new C&Q (Commissioning & Qualification) program (PVP, PQP, URS, CARA, CADR, PQP, PQ , PQP Report) and Qualification of Laboratory Equipment for the re-launched of Tylenol Extra Strength Gel caps, Tylenol Arthritis and Motrin 500mg. • Participate in the review and approval of Packaging Line Trial, Packaging Performance Qualification and Product Packaging Performance Qualification documentation as part of QSE-6 Packaging remediation activities Consent Decree. Giving guidance in the preparation and approval of Test Incident Reports and Packaging Deviations related to this remediation activities. • Review and approved cleaning validation protocols for the coating area as part of re-launched activities for Tylenol Arthritis (TAR). Review and approved cleaning development phase 1 and phase 2 TAR batch records and cleaning validation batch records.• Participate and support the design and implementation phases of new processes for the QSE’s 9 (Plan remediation phases). Working with IOQ protocols of commissioning of segregation of packaging line 3, 4, 5 and 6. Also working with AHU-19R providing guidance in the design and generation of validation documentation. • Recommends, evaluates and approves validation strategies in re-launch of RRG Project, Packaging Components changes such as Charm Project, Drawing Remediation, Cleaning Validation of Washer and Dryer Granulation Area.



Ultimate Solutions Corp

• United Kingdom
• Financial Services

• Packaging Process and Reliability Engineer

  • Jun 2010 - Apr 2012

  McNeil Health Care LLC consultant:Supervised packaging mechanics and packaging process.(McNeil Healthcare LLC Las Piedras) Improve packaging process using tools such as FMECA, Lean Manufacturing. Coordinate and create preventive maintenances to the packaging machines shop floor.Answer compliant from costumers.Assist in the events investigation preparing equipment technical assessments. Gave support during packaging qualifications and packaging process validation. Coordinate spare parts purchase and dealing with packaging vendors.



NYPL Service Inc.

• Project Coordinator / Engineering Validation Specialist

  • Oct 2010 - Jan 2012

  • Merck Las Piedras P.R consultant.Packaging Segregation Project Phase IISupervised construction activities of packaging area renovation. (Merck Las Piedras )Construction activities include modifications in Air Handling Units, Fire Protection System, Compress Air System, Securities System, and Electrical System. Coordinate with the outsourcing vendors the construction activities. Provide all necessary documentation such as drawings, construction submittals, air balance reports for the execution of facilities commissioning protocols and qualification protocols of the air-handling units.Schering Plough Las Piedras Consultant USP Water System Point of Use 11 at Small Scale Facility Prepare, executed and close activities of the Operational Qualification of the USP Water Point of Use Control System at Small Scale Facility.Equipment Qualification Review Verify the qualified state of manufacturing laboratory, packaging and utilities equipments based on their change authorizations, drawings, qualification package and notice of events related to this equipment and determined if they need revalidation or corrective actions Engineering SOP’s Consolidation Project Evaluate and consolidate Engineering Department SOPs as part of their (3) years revision.Packaging Segregation Project phase 1Owner of the close qualification activities regarding Packaging Segregation Project Change Authorization Prepared and closed the qualification activities regarding Change Authorization for the IOQ Unscrambler Machine at Packaging Area. Prepared, executed and close IOQ for Air Handling Units, Facility Commissioning, Commissioning for the Air Handling Units Control System, IOQ Unscrambler Machines and Decommissioning Blister Machines.



International Scientifc-A

• Puerto Rico
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance / Technical Engineer / Engineering Validation Specialist

  • Feb 2007 - Oct 2008

  • Biovail, Dorado P.R consultant.Audit and approved Drawings regarding pharmaceutical critical systems such as DI Water, Soft Water , Potable Water, HVAC and Compress Air Systems. Prepared Validation Master Plan Revision for Computerized System Inventory 21 CFR Part 11 for Dorado and Carolina Sites Rev 1 and Rev 2.Review and approve qualification protocols (VMP, URS, FRS SDS, IOQ), regarding utilities, facilities, process and packaging areas.Technical Engineer responsible and supervise two engineering validation specialists regarding the validation activities of the shut down Carolina plant. Prepared and executed qualification protocols and change controls to comply with GMP compliance upgrade phase III. To improve quality and appearance of most of the manufacturing rooms, the air conditioning, compressed air system and the illumination of the facility.



Zaycor Compliance and Consulting

• Quality Assurance Specialist

  • Sep 2006 - Feb 2007

  • Biovail, Dorado P.R consultant .Review and approve qualification protocols (VMP, URS, FRS SDS, IOQ) regarding utilities, facilities, process and packaging areas. • Biovail, Dorado P.R consultant .Review and approve qualification protocols (VMP, URS, FRS SDS, IOQ) regarding utilities, facilities, process and packaging areas.



Caribbean Validation Services

• Process Engineer / Engineering Validation Specialist

  • Feb 2004 - Sep 2006

  • Merck Sharp and Dohnme, Arecibo P.R.Prepared Qualification Protocols (AIQ, IQ and OQ) for the LAKSO Reformer 990 Anti Static Bar Monitoring System for Bottle Packaging Lines #2, 3 and 4.• Ethicon Johnson & Johnson, San Lorenzo P.R. Process Engineer (Project Leader) responsible of the Elimination of 100% Minimum Needle Pull Inspection on size 3/0, 2/0, 0 &1 Silk Codes Attached to Mechanically Drilled Needles, and Prolene Channel Codes. Re-layout of Line 2 and Line 4 to improve materials flow, handling and improve capacity in the shop floor. Process Engineer in products transfer from Scotland to Puerto Rico (Magnolia Project).. Prepared and executed functionality test and qualified manufacturing equipment to deliver to the shop floor.Deal with the multidisciplinary team (equipment vendors, quality assurance, EHS inspections and buy the spare parts) to achieve milestone and project schedule.• Pfizer PGM, Caguas P.R.Prepared and performed Qualification Protocol for the Lock Model 30+ Metal Detector (IQ, OQ and PQ).Work in a protocol generation process and performed a re-qualification of an MG2 encapsulation machine.Work in the qualification protocol for the introduction of a new container closure system 60cc and 120cc Squeeze and Turn (S&T) Bottle / 28mm, 38mm CR Closure System.Worked in protocol generation process and performed Qualification Protocol (IQ, OQ) and Packaging Process Validation (PPV) for the introduction of GEODON 20mg, 40mg, 60mg and 80mg in 45cc / 60cc Squeeze and Turn Bottle (S&T) / 28mm CR Closure System. • Pfizer PPLC, Vega Baja P.R.Worked in protocol generation process and performed Packaging Performance Process Qualification for Zyrtec Chewable 10mg, Installation and Operational Qualification for the Ulhmann Cartoner C2205 for Zyrtec Chewable 5mg, 10mg. Also in Qualification Protocol (IQ, OQ) for the introduction of 45cc / 60cc, 120cc / 180cc Squeeze and Turn Bottle (S&T) / 28mm, 38mm CR Closure System.