Mark DeLuca P.E.

51 Dawn Road

Levittown, PA 19056

(215) 752-1619


OBJECTIVE: Seeking projects that involve current Good Manufacturing Practice (cGMP) or The International Conference on Harmonization (ICH) Q7A regulated, automated, chemical and/or biological processes with the opportunity to design, start up, commission and/or validate: computer systems, automated processes and process equipment.


Del-Engineering Contract Engineer (6/92 –present)

Clients include:


Synthes  West Chester, PA – Senior Computer System Validation Lead

Managed a team of six CSV specialists/engineers to resolve issues stemming from a CAPA for missing Computer System Validation (CSV) documentation. The team conducted a GAP analysis for 400+ manufacturing and laboratory computer controlled systems. The GAP analysis identified 40+ systems that were remediated over a 6-month period. The team created of all required CSV Equipment Validation deliverables for GxP-relevant systems identified during the project.

·         Provided support to inventory, perform legacy review, assess GxP risk and perform revalidation/remediation.

·         Guided, mentored and/or coached the client through the roll out and transition into the new CSV equipment validation process methodology.

·         Tracked and reported progress of the team to management.

Output was all system’s CSV documents in compliance with 21 CFR 820.75, 21 CFR part 11 and  ISO 13485 as well as corporate CSV policies.


McNeil  Fort Washington, PA – Quantic Verifier   (Auditor)  

Audited the quality systems to determine if the agreement between the client and the FDA (the consent decree) was being followed as a  Consent Decree Remediation & Verification Consultant. Reviewed and confirmed the written procedures for clarity, executability and regulatory compliance.

Evaluated evidence generated over months of operation to determine if the client’s actions were compliant and sustainable.

Verified following steps:

·         Validation process steps: process validation, validation master plan, validation plans, cleaning validation, Computer Systems Validation (CSV) and equipment validation.

·         Package development and specification process step.

·         Investigations and Corrective and Preventive Actions (CAPA) process step.

·         Liquid packaging operation.

Output was audit reports attesting that the client was in compliance with the consent decree.


Daiichi Sankyo  Bethlehem, PA – Validation Engineer   

Wrote and executed the validation test scripts for a solid dosage packaging line. This line included unscrambler, filler, cottoner, capper, induction sealer, re-torquer, labeler and shrink wrapper. Output was a validated packaging line.


Merck  Westpoint, PA – Validation Engineer   

Helped prepare cost estimate to bid on an 8 month validation of a class C aseptic manufacturing space with over a dozen air handlers controlled by a Siemens Apogee Building Automation System (BAS) which controlled security access and fire alarms as well as the Heating Ventilation and Air Conditioning (HVAC). Output was a cost estimate for a proposed validation project.


Unit Pack  Cedar Grove, NJ – Validation Consultant  

Resolved 483’s on a packaging line stemming from an incomplete validation protocol. Completed the protocol and recommended changes to the quality system to reduce exposure to further regulatory scrutiny. Output was a closed out reply to a 483 that stood the test of a follow up FDA inspection with no further concerns.


MedImmune Philadelphia, PA – Validation Engineer  

Wrote the validation test scripts, Installation Qualification (IQ) and Operational Qualification (OQ), protocols for a syringe filler and packaging line. This line included unscrambler, filler, vision inspection, tray former, induction sealer and labeler. Output was signed validation test scripts ready for execution by the client.


Merck  Westpoint, PA – Validation Engineer   

Preformed a gap analysis for exposure to production risk in preparation for allocation of capital for all the vaccine production facilities at the site. Output was an audit report outlining compliance and process risks.


Ohm Laboratories New Brunswick  NJ  – Validation Engineer  

Wrote and executed IQ and OQ protocols for generic solid dosage manufacturing equipment including metal checkers, tablet presses, capsule fillers, coating tanks, V-blender, fluidized bed dryer, sieve shakers, fluidized bed dryer bag filter washer and checkweighers, label checkers and bar code scanners. Output was validated equipment.

Samuel Adams Brewery  Breinigsville, PA  – SOP Writer  

Wrote Standard Operating Procedures (SOP) for the plant. Walked down the process with the operators and modified the SOPs to accommodate the equipment and processes needed to make Sam Adams Style Beer. Photographed equipment labeling the elements that the operators would use. The output was SOPs and training manuals.

Johnson & Johnson Ortho Clinical Diagnostics  Raritan, NJ  – Validation  

Developed a manual cleaning procedure that was repeatable and not operator dependent. Tested cleaning steps, wrote SOPs, validated the cleaning process. Development involved soiling parts and cleaning them. Testing included swabbing parts for bio-burden and TOC. Collaborated with an independent laboratory to develop recovery factors for the surfaces and soils under consideration. The output was a validated and approved backup procedure to wash parts when the automated equipment was not available.

GlaxoSmithKline  Upper Merion, PA SPA Project Manager  

Closed out outstanding issues on protocols for validation of electronic data collection from the clinical trial scale solid dosage manufacturing equipment including wet mixers, granulator, tablet presses and other clinical scale equipment. The output was signed and approved IO OQ protocols.

Advance Automation Associates  Exton, PA  – Process Engineer  

Wrote the Factory Acceptance Test (FAT), Site Acceptance Test (SAT), IQ and OQ protocols for a Programmable Logic Controller (PLC) controlling a Clean in Place (CIP) system for a veterinary vaccine plant.. The output was protocols for the client to execute.

Trident Engineering  Newtown, PA  – Process Engineer  

Analyzed and sized condensers for alcohol recovery to comply with air permits using AP42.

Wrote and executed commissioning, IQ and OQ protocols for an Active Pharmaceutical Ingredient (API) inhaled anesthetic manufacturer.


Johnson & Johnson Ortho Clinical Diagnostics  Raritan, NJ  – Validation Consultant   

Part of a three-member team doing a GAP analysis for the Ortho Clinical Diagnostic (OCD) division’s validation documents to evaluate their compliance with current standards. Reviewed all the equipment documents. Served as document librarian for the duration of the project. Organized a validation records center for faster document retrieval. Evaluated each document for compliance to current cGMPs (21 CFR parts 11, 21 CFR 58, 21 CFR 210, 21 CFR 211, 21 CFR 640, 21 CFR 820). Identified areas based on their criticality to the process to determine where additional validation efforts may be required to stay compliant with current regulatory environment. Output was a newly created database with each piece of cGMP equipment listed and a risk based rating of the state of the supporting documents for that equipment.

Bristol Myers Squibb  New Brunswick, NJ – Engineer   

Validated and qualified equipment used for the Bristol Myers Squibb Co. Clinical Supply Operations Department for compliance with cGMP and European Union Regulations. Equipment included table presses, encapsulators, pan coating equipment, automatic checkweighers, a Glatt fluidized bed and various sizing, milling and grinding units.

Validated and qualified API synthesis facilities. Equipment included a breathing air system for operators, portable vessels and reactors that plugged into an S-88 based Delta V Distributed Control System (DCS) system.

Qualified high containment laboratory facilities. Equipment included two walk in containment hoods, operator breathing air, compressed air, laboratory nitrogen distribution utilities, clean steam and process vacuum system. Output was qualified and validated equipment.


Merck  King of Prussia, PA– Engineer   

Qualified a liquid nitrogen system supplying cryogenic tissue culture vaults.

Output was qualified equipment.


Centocor  Fort Washington, PA– Engineer   

Qualified a laboratory monitoring system that phoned responsible personnel to notify them of alarm conditions. Output was qualified equipment.


Merck  West Point, PA  – Engineer   

Wrote Factory Acceptance Test (FAT) protocols for a Delta V system for Merck’s Human Papilloma Virus (HPV) vaccine facility. This S-88 based facility included Clean in Place (CIP), Steam in Place (SIP), media/buffer prep and standard recipes. Output was signed validation documents ready to be executed.


Jacobs Engineering  Conshohocken, PA – Engineer   

Performed on site engineering for Jacobs’ clients: Merck, Wyeth, Kimberly-Clark, Eli-Lilly, and Schering-Plough.

·         Startup and validation of a Wyeth project which was a two year 600 million dollar Biotech facility at GI in Andover, MA. Operation of Wyeth’s new cell culture plant involved multiple PLCs controlled by SCADA that ultimately was directed by an MES system. The design followed S-88 practices. Processes validated included: clean steam, De-Ionized (DI) water, Water for Injection (WFI) water, filtered potable water, glycol and chilled water cooling utilities,  plant CIP and SIP,  bioreactors,  media and buffer prep, filtration and chromatography.

·         Merck project included validation of Apogee building automation system and process compressed air for a varicella-zoster virus (VZV) HHV-3, vaccine facility.

·         Kimberly-Clark project validated a sample tracking system for a product stability testing facility.

·         Eli-Lilly project included IQ and DQ for an upgrade to the Humulin facility, which split a WFI water system into two independent loops.

·         Schering-Plough project was to organize preventive maintenance records for an audit.


Merck  West Point, PA – Computer Validation Quality Assurance Associate

Reviewed computer systems for compliance with cGMP and 21 CFR Part 11, 21 CFR 210 and 21 CFR 211 requirements. Audits included PLCs, Building Automation Systems, SCADA, LIMS, chromatography systems and custom software. Output was audit reports showing state of compliance.


Applied Control Engineering Inc. New Castle, DE – Process Control Engineer    

Applied Control Engineering Inc. is a system integrator serving the chemical and pharmaceutical industries. Programmed three Allen-Bradley PLC-5s adding new I/O and associated control logic for a specialty chemical plant.


BioKinetics  Philadelphia, PA – Automation Engineer                              

BioKinetics is a design/build engineering firm serving the biotech and pharmaceutical industries. Prepared Functional Requirement Specifications (FRS) and Valve Sequence Tables (VST) for a project with sixteen Allen-Bradley PLC-5/80s.


Merck  Westpoint, PA  – Chemical Engineer  

Wrote FDA regulated automation documents including FRS, Detailed Design Specification (DDS), IQ, OQ, SAT, and FAT. Supervised, as part of a team, the construction of a $170 million pneumonia vaccine manufacturing plant. Had complete responsibility for a half million-dollar skid within the fermentation suite. Shared responsibility with five engineers for automating the $40 million fermentation suite. The fermentation suite was controlled by both Allen Bradley PLCs and a DCS system. Output was a working vaccine production facility.


Rohm & Haas  Philadelphia, PA – Process Engineer  

Responsibility was a $1.5 million automated tank farm renovation. Ran the project from design through startup while full-scale manual production was taking place. Prepared P&IDs taking them through multiple approval cycles and reviews including production approval, safety, health and environmental approval and business team capital expenditure approval. Supervised detailed design. Coordinated the efforts of a team of piping, instrument, electrical and structural designers in preparing all the drawings and details. Involvement with system startup including tuning loops, stepping through sequences, water runs and chemical startup.

Output was a working tank farm feeding a herbicide manufacturing operation.


Honeywell  Fort Washington, PA – Process Control Engineer   

Added INIT alarms to the HMI card and tested the change. Programmed in Pascal. Tested code in CL. Output was code changes and all the supporting software life cycle documentation.


Epsilon  New Castle, DE – Controls Engineer  

Epsilon is a polypropylene manufacturer. Responsibility was to review the as-built programming for three Honeywell IPC-623 PLCs against license. Output was as-built drawings.


American Cyanamid  Parkersburg, WV – Senior Process Engineer  

Assembled and installed six different pilot scale (~25 gpm), ultra filters (UF) and Reverse Osmosis (RO) units from three different vendors for evaluation of their effectiveness in recovering trace levels of antibiotic remaining in the process waste water. Output was a report recommending the best RO unit for this operation.


Ecochem  New Castle, DE – Senior Process Engineer  

Ecochem was a DuPont and ConAgra joint venture to make biodegradable plastics. Responsibility was to supervise the 12 to 8 am shift of the startup team for a $25 million plant. The team included four technicians and three mechanics. Tuned controllers on the Bailey Infi 90, Programmed Modicon 984-685 PLC. Output was a small scale facility that provided data to show a larger facility was not worth further investment.


Direct Employee (6/82 - 6/92)

Chessell Inc. Newtown, PA – Product Development Engineer

Programmed in C, in a UNIX environment, developing software for industrial equipment.

Output was embedded software for the company’s products.


EG&G Princeton Applied Research Princeton, NJ – Engineer

Programmed in Forth, developing hardware and software for laboratory equipment.

Output was embedded software for the company’s products.


Rohm & Haas Bristol, PA – Process Development Engineer

Production plant engineer responsible for troubleshooting and de-bottlenecking processes. Output was daily technical support to a manufacturing operation.



Stevens Institute of Technology Masters of Pharmaceutical Manufacturing through the Mechanical Engineering department GPA 4.0/4.0 (2012)

Villanova University completed Project Management certificate program (2002)

New Jersey Institute of Technology completed 96 credits out of 130 needed toward a BS in Electrical Engineering GPA 3.9/4.0 (Night School 1987-1992) Tau Beta Pi

Polytechnic University BS Chemical Engineering GPA 3.0/4.0 (1982) Omega Chi Epsilon 

Professional Engineer (1992) Licensed in PA, NJ and DE