Continuous Improvement Quality Engineer

Mark G. Lombardo Carlsbad, CA *****; *************@*******.***; 760-***-**** (cell)

Summary of Qualifications

Strong knowledge of 21CFR820 and 21CFR11; Adept at investigating, and closing out deviations, CAPA’s, NCR’s, OOS, complaints, audits, and BR (batch record) reviews.

Knowledgeable with all kinds of process and packaging equipment such as pumps, filtration systems, homogenizers, heat exchangers, mixing kettles, and chemical delivery systems.

Thorough understanding of scale-up procedures from lab to pilot to full-scale manufacturing.

Have worked in many plants trouble-shooting manufacturing problems in the U.S. and internationally (Italy, S. Korea).

Just as comfortable in the lab as in the plant. Very familiar with cGMP’s and cGLP’s. Also, good knowledge of functional testing and lab instruments/equipment.

Very comfortable working with cross-functional teams and external organizations to improve quality, trouble-shoot manufacturing problems, and implement process improvements.

Good knowledge of Lean 6-sigma and continuous improvement efforts based on the Toyota manufacturing method.

Have written/developed formulas, raw material specifications, manufacturing procedures, finished good specifications, and batch records. SME on “cold chain” domestic & international shipping validations.

Very familiar with equipment/process validations and the 3 cornerstones of manufacturing: cycle times, yield, and quality. Familiar with many utility/facility qualifications such as d/i water systems, air compressors, boilers, chillers, temperature mapping of environmental rooms, etc.

Experience/exposure to CSV, GAMP 5, and Excel spreadsheet validation.

Comfortable working in eDMS (Agile/Documentum) and (Global) Trackwise for deviations, investigations, & CAPAs.

Work Experience

Thermo-Fisher Scientific, Carlsbad, CA, October 2018 – February 2024

1.Sr. Quality Engineer (Nov. 2020 – Feb. 2024; PSG Group) Quality reviewer & approver for all CQV documentation. Worked with CQV specialists to investigate/resolve deviations and non-conforming runs. Wrote SOP for Excel spreadsheet qualification and lead effort to implement it. Set-up a Data Integrity (DI) Program from the ground up, adhering to Corporate policy, including Equipment assessments and DI Observational Oversight. Worked with IT/Automation engineering to implement solutions for data backup, Audit Trail access & review, and establishing User Access accounts and security. Worked in (Global) Trackwise to lead investigations, conduct CAPAs/Effectiveness Checks, and clear deviations from GMP batches. T-F Qualified trainer for new hire quality training.

2.Sr. Validation Engineer (Oct. 2018 – Nov. 2020; LSG Group) Validation resource for all CQV activities in LSG Carlsbad (RUO environment, primarily). Validated various pieces of equipment including -80C freezers, -20C trailers/cold rooms, autoclaves, glasswashers, excel spreadsheets, some CSV validation (Bartender), etc.

BD Biosciences, San Diego, CA [Consulting]; Senior Validation Specialist, October ’16 – September ‘18

Process Validation lead for a new plant BD opened in Tatabanya, Hungary. Responsible for writing/creating several PQMP’s (process qualification master plans). Responsible for writing protocols/reports for “cold chain” studies for shipping antibodies, purified/conjugated products, and cell lines from San Diego to Hungary. Responsible for writing manufacturing process validations for the various manufacturing steps in BD’s process: cell culture, purification, conjugation, and formulation & packaging. Defined requirements document for qualification of d/i water system, temperature mapping of environmental rooms, and compressed air systems.

Edwards Lifesciences, Irvine, CA [Consulting]; Senior Validation/Manufacturing Engineer, October ’15 - October ‘16

Led a Latex Balloon Mfg FAI/TFIQ cell (Retrospective Validation) which measured and documented critical dimensions of over 15,000 mandrels and other fixtures used to make balloons for catheters in Edwards’ Critical Care group. Reviewed and provided feedback on technical summaries, protocols, and reports for various validation efforts in Balloon Manufacturing. Helped to develop a new procedure for future mandrel purchasing that involved qualifying current/new mandrel vendors, requiring them to do future FAI’s, and then creating a receiving router for Edwards’ internal receiving group to review vendor paperwork and verify sample measurements before releasing new (mandrel) trees to manufacturing. Wrote protocols and reports (IQ/OQ) for validation of clean room equipment for a new heart valve manufacturing line. Qualified a differential pressure monitoring system and helped to validate a new d/i water system (mainly on the distribution side, IQ/IQ software/OQ/PQ).

Illumina/Inovio, San Diego, CA [Consulting]; Senior Manufacturing Engineer, October ’14 – September ‘15

Reviewed and updated several PVMP’s (Product Validation Master Plans) with all attachments. Conducted gap analysis to verify that all documents referenced in the PVMP and attachments existed in the EDMS and were complete and approved. Reviewed all FMEA’s that were referenced in the PVMP’s and updated as necessary. Updated Critical Process Controls based on project updates/changes. For several programs, reviewed DHF and Requirements Traceability Matrix (RTM) to ensure that all requirements defined for these projects were tested in test protocols, especially software requirements. Reviewed BR (batch records) and closed out deviations/CAPA’s/NCR’s. [Inovio] CSV: wrote a network qualification, re-wrote IT SOP’s, and validated test scripts for a new version of ACE (Adaptive Compliance Engine which is a new EDMS).

ENJOY/USP (Ultimate Salon Professionals), Oceanside, CA; Director of Manufacturing, July ’13 – September ‘14

USP is a salon hair care company with several brands. Their ENJOY brand is sold exclusively to professional salons and their HBL (Health Beauty Life) line is sold to mass market channels. USP had used contract manufacturers to compound and package all their products. They decided to do their own manufacturing and hired me to lead that effort. This included writing SOP’s, batch records, safety procedures, equipment selection/qualification, etc. I was also responsible for facilities/utilities qualifications (boiler, air compressor, chiller, d/i water system, etc), equipment selection, equipment integration, process & equipment validations, etc. Trained 3-4 compounders/material handlers on usage of batching and filling equipment.

Genmark Dx (Roche), Carlsbad, CA; Senior Manufacturing Engineer, August ’11 – June ‘13

Scaled-up GNMK’s reagent business from a 1x to 10x level (signal buffers, PCR Mixes, and depo solutions). Led an effort to get a secondary source approved/qualified for oligos (signal probes, capture probes, and primers). Led an effort to reduce overall time and increase efficiency in reagent manufacturing by semi-automating the process: labeling of vials, filling reagent, and cap/torque of vials. Kaizen project goal of 40% reduction achieved. Formulated all my own reagents for testing/analysis: signal buffers, PCR Mixes, depo solutions, and pooled amplicon testing solutions. Lead an effort to get a secondary source approved/qualified for GNMK’s phosphoramidites and ferrocene labels. Worked with GNMK vendors to get other key ingredients (dNTP’s, for example) supplied in larger aliquots as we scaled-up reagent manufacturing. Wrote qualifications for and conducted temperature mapping of various environmental rooms & freezers/ovens.

Neutrogena/Gen-Probe, Los Angeles/San Diego, CA [Consulting]; Senior Manufacturing/Validation Engineer, June ’09 – August ‘11

Neutrogena: I participated in a comprehensive cleaning validation re-mediation project on kettles and associated manufacturing equipment such as pumps, filters, homogenizers, etc. Helped to qualify cleaning skids which were designed & manufactured by an outside vendor. Helped to write SOP’s and IQ/OQ’s for these cleaning skids. Re-wrote current cleaning procedures and standardized them. Also, worked in the lab doing coupon studies to characterize and rank several new cleaning detergents. Gen-Probe: conducted risk analysis and gap analysis of HVAC system in manufacturing suites. Investigated validation deviations and initiated NCR’s/CAPA’s where appropriate. Wrote PRA’s (product risk assessments) to help close these investigations out.

Axelgaard Manufacturing Corporation (AMC), Fallbrook, CA; Senior Chemical Manufacturing Engineer, September ’05 - May ‘09

AMC is a class 2 medical device company manufacturing electrodes (both muscle & pain/nerve stimulation) using UV-cured hydrogels. I developed a new mixing procedure for batch gels that reduced waste by 15-25% by eliminating air bubbles introduced during regular batch mixing. I wrote all process validation protocols & reports, most IQ/OQ/PQ’s, and most changes to batch records, finished good specifications, and raw material specifications. I functioned as a liason between R&D and manufacturing to facilitate new product transfers. Polymer Chemistry - worked with R&D to optimize gel formulations by varying levels of initiator, catalyst, cross-linker, and polymers. Led a qualification of AMC’s in-line chemical delivery system and was primarily responsible to re-design the next generation model. Monitored and analyzed manufacturing trends. Worked closely with QC/QA to decide on product recalls, streamline quality procedures & systems, and trouble-shoot complex manufacturing problems.

Education

1.American Intercontinental University, Los Angeles, CA. Masters in Information Technology.

2.Santa Clara University, Santa Clara, CA. MBA.

3.Tufts University, Medford, MA. B.S. Chemical Engineering.

Professional Organizations – Member of ISPE (International Society for Pharmaceutical Engineering)

Languages – Mandarin Chinese, moderate proficiency; have traveled extensively in East Asia for business.

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