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DPS | Better Engineered Solutions

Better Engineered
Solutions

Our People

WE PUT YOU FIRST

Structure and process play their part in engineering but at DPS we think business is personal, so we engineer everything around you. Productive partnerships thrive on good rapport. We place great emphasis on rapid response and effective communication. Response to us isn’t just about speed; it’s about giving you accurate, reliable information and ideas that you can act upon and trust.

We select our people based not only on their potential and technical excellence, but also on their principles and values. Their commitment to integrity is a critical factor in our decision to employ them. Our engineering teams take full ownership of the responsibility and success of every project. You’ll find them easy to reach and ready to help. We always strive to go above and beyond what’s expected.

With DPS, your projects are in safe hands. Always. 

  • Principal Consultant, Director DPS Strategic Consulting Group

    Sue Cooke. BSc.

    Principal Consultant, Director DPS Strategic Consulting Group

    Sue Cooke. BSc.

    Principal Consultant, Director DPS Strategic Consulting Group

    Sue is a Principal Biopharma Consultant and Director of the DPS Global Strategic Consulting Group. Sue has over 25 years’ experience in the Biopharmaceutical sector in Ireland, UK and mainland Europe engaged in Design Consultancy, Project and Program Management. Sue has a depth of experience in the early phase development of Biopharma projects leading feasibility and concept design studies for new facilities as well as extensive experience managing full design and construction project implementation. Her experience covers a broad range of facilities from laboratories, development and manufacturing facility projects in the drug substance and drug product areas, primarily for Biologics and ATMPs.

  • Principal Consultant - CQV and Regulatory Affairs

    Aidan Harrington. PhD

    Principal Consultant - CQV and Regulatory Affairs

    Aidan Harrington. PhD

    Principal Consultant - CQV and Regulatory Affairs

    Dr. Harrington is a Principal Consultant with DPS based in Ireland, who has been working in the Pharmaceutical Industry since 1992. Aidan has worked in QA, Validation and Engineering roles in both manufacturing and capital project environments for the pharmaceutical industry and is an expert in US FDA and EU cGMP regulations. He has extensive regulatory inspection exposure experience; EMA, FDA and HPRA. Aidan has played significant roles on the planning and implementation of Commissioning and Qualification programs for large capital projects including implementation of Quality Risk Management principles from concept design phases to product Process Validation for sterile and biologics drug substance manufacturing facilities. Aidan offers consultancy to a range of clients in areas such as concept design for cGMP compliance, risk reviews, inspection pre-audits, technology transfers, new technology assessments and contamination investigations.

  • Principal Consultant - Parenteral Manufacturing & Facility Design

    Barry Starkman

    Principal Consultant - Parenteral Manufacturing & Facility Design

    Barry Starkman

    Principal Consultant - Parenteral Manufacturing & Facility Design

    Barry Starkman is a Principal Consultant for parenteral manufacturing and facility design working from our Framingham, Boston office. Barry is a biopharmaceutical professional with over 30 years’ experience in large sterile manufacturing facility design, start up and operation and has held engineering and executive manufacturing leadership roles for Merck and Genentech in the USA. He has a unique mix of manufacturing, engineering and senior corporate leadership experiences which we believe provide real value and insight into the early phase design and implementation of sterile manufacturing facility projects and business processes. His experience includes vaccines and potent compounds. Barry was responsible for the development of the performance based exposure control limit program for potent pharmaceutical compounds at Merck. He was responsible for design and implementation of a number of significant high capacity state of the art, isolated sterile filling facilities for Merck and Genentech. Barry provides strategic planning, early project feasibility and pre-concept design consulting to DPS clients and internal teams in USA and EU as well as expert advice on operational excellence, lean design and operations and business improvements.

  • Principal Consultant - Quality & Regulatory Affairs

    Stephanie Gaulding

    Principal Consultant - Quality & Regulatory Affairs

    Stephanie Gaulding

    Principal Consultant - Quality & Regulatory Affairs

    Stephanie has over 20 years of experience in quality systems and validation program management in FDA and EU regulated companies and over 3 years providing quality and regulatory consulting services. She has held site Quality Management positions with responsibility for development, redesign, streamlining and implementation of quality systems and validation programs to comply with global regulatory requirements and industry best practices for drugs, biologics and medical devices. As a proven leader Stephanie has ability to identify root causes and quickly resolve issues, and implement efficient business processes to support ongoing compliance. She has also been responsible for the remediation of quality systems at several pharmaceutical and medical device manufacturing sites. She is an ASQ Certified Quality Auditor and Certified Pharmaceutical GMP Professional experienced in auditing contract manufacturers, raw material suppliers, equipment suppliers, computer system vendors and component suppliers. Stephanie also has solid understanding of drug, biologic and medical device product development, manufacturing, handling and control processes. In addition, she has developed and validated Quality Control in-process and release methods including analytical chemistry and microbiological/biological procedures.

  • Process Design and Safety Specialist

    Mike Clucas. BSC.Chem.Eng, AMIChemE

    Process Design and Safety Specialist

    Mike Clucas. BSC.Chem.Eng, AMIChemE

    Process Design and Safety Specialist

    Mike Clucas is senior chemical engineer with significant process safety, ATEX and environmental regulatory expertise. Mike carries out environmental and ATEX consulting for DPS’s clients in Ireland and mainland Europe.
    Mike’s has developed his expertise through a varied career in key process engineering and technical services roles for major small molecule pharmaceutical companies such as Novartis, BMS and Roche as well as design and process safety lead roles for major global engineering consulting firms.
    Mike’s area of expertise includes distillation, solvent recovery, solvent handling, vent header design, explosion protection, cryogenic abatement, incineration, biological waste water treatment, scrubbing and anaerobic digestion, high containment cytotoxic facilities, Seveso and IPPC licensing.

  • Lead Process Engineer

    Mark White. B.Eng. Chem., C.Eng., MIChemE

    Lead Process Engineer

    Mark White. B.Eng. Chem., C.Eng., MIChemE

    Lead Process Engineer

    Mark White is a lead engineer with over 21 years experience working in the chemical, pharmaceutical and related industries. Mark has combined management, production site and design office experience and has significant breadth and depth of experience across key process engineering activities. He has a particular interest in containment, process safety and EU directive compliance, and is a key technical expert with in DPS in these and other areas. Mark is a Chartered member of the Institute of Chemical Engineers and the DPS member of the DIERS User Group.

  • Process Lead / Technical Oversight

    Indu Conley

    Process Lead / Technical Oversight

    Indu Conley

    Process Lead / Technical Oversight

    Indu is the Process Engineering Department Manager with DPS in Boston, MA USA. She has more than 15 years of experience in the biopharmaceutical industry with significant experience in large-scale mammalian cell culture processes. Her design experience includes all stages of biologic process unit operations, including, harvest, TFF systems, chromatography, and filtration systems. Indu began her career on the owner side of the business and gained significant experience as a lead engineer for a biologics manufacturing facility; this experience brings valuable operational and plant experience to her design approach. Indu is an active member of ASME BPE (American Society of Mechanical Engineers Bioprocess Equipment) in which she serves on the standards committee for design.

  • Head of ATG Operations

    Niall Dillon. B.Tech., MPMP

    Head of ATG Operations

    Niall Dillon. B.Tech., MPMP

    Head of ATG Operations

    Niall Dillon is Head of Operations for DPS’s Advanced Technology Group. With over 20 years’ experience in the Design, Project and Construction Management of complex projects in the Advanced Technologies sector, his responsibilities have included Program Management, Contracts Management, Cost Controls, Financial Modelling and implementation of Risk Management Programs on large $Billion capital investments. Niall has a solid understanding of the challenges of delivering large scale projects at engineering, project manager and client levels.

  • Biotechnology and Biocontainment Specialist

    Stephen Fitzpatrick. PhD.

    Biotechnology and Biocontainment Specialist

    Stephen Fitzpatrick. PhD.

    Biotechnology and Biocontainment Specialist

    Dr. Stephen (Steve) Fitzpatrick is a Biochemical Engineer and Principal Biotechnology Consultant with DPS. He has over 35 years of experience in the biological, pharmaceutical and chemical process industries and has been published in many leading journals. Steve is the inventor and holds the patents for the Biofine process for conversion of cellulosic biomass into levulinic acid.
    Steve’s specialist expertise covers a range of technologies, summarized as follows: - Recombinant DNA processes using bacterial, mammalian, viral, transgenic and tissue therapeutic protein sources - Development of large scale bioreactor technology and production scale chromatographic methods for purification of proteins and live virus - Biocontainment - Bacterial fermentation based process optimization via computer modelling - Development and design of processes for chaotrope extraction and protein refolding - Development and design of processes involving various mammalian cell types; human fibroblasts, human fetal kidney cells, dendritic cell lines, hybridomas, CHO cells, and mouse 3T3 cells - Scale up and design of processes for human tissue growth, human RBC decontamination, and cell/tissue processing for autologous, allogeneic, and xenogeneic transplantation - Algae and fungal culture - Plasma Fractionation - Tissue extraction.

  • Commissioning and Qualification Manager

    Marianne O’Sullivan. PhD.

    Commissioning and Qualification Manager

    Marianne O’Sullivan. PhD.

    Commissioning and Qualification Manager

    Marianne has over 15 years’ experience in commissioning & qualification of major pharmaceutical and biopharmaceutical facilities across a number of sectors; sterile manufacturing, solid dosage and small molecule API facilities. Marianne has in-depth knowledge of the ASTM E-2500 verification process and has managed the implementation on various projects and has helped clients develop risk based strategies for commissioning and verification of new and upgraded development and manufacturing facilities.

  • Program Manager, ATG Operations

    KEVIN FENTON. BSC. (MECH. ENG)

    Program Manager, ATG Operations

    KEVIN FENTON. BSC. (MECH. ENG)

    Program Manager, ATG Operations

    Kevin is a Senior Program and Project Professional for DPS’s Advanced Technology Group (ATG), with extensive international experience in engineering & design, construction, commissioning/qualification and start-up of facilities for over 20 years. He has extensive experience across diverse industrial sectors ranging from pharmaceutical to semiconductor. Kevin’s particular expertise is in the set up of projects for successful delivery early in the life cycle by the clear identification of overall business goals and project objectives, establishing and communicating roles and responsibilities. He is an early adopter of lean principles enabling and releasing maximum productivity while driving waste and inefficiency at program, project and organisational level. His key strength is having a pragmatic and focused data driven decision-making process, ensuring consistent focused delivery and establishment of correct program culture through team and project integration, specialising in integrated project delivery.

  • Senior Pharmaceutical Engineer, Small Molecule API facilities

    Pat Flynn B.Eng. Chem., AMIChemE

    Senior Pharmaceutical Engineer, Small Molecule API facilities

    Pat Flynn B.Eng. Chem., AMIChemE

    Senior Pharmaceutical Engineer, Small Molecule API facilities

    Pat is a Senior Pharmaceutical engineer with a focus in the area of small molecule API facility process design. Pat is recognised as one of the industry leading peers in his area with over 25 years’ experience in design and implementation of complex chemical API facility projects. He has comprehensive expertise in all aspects of API process facilities including reactors, crystallisers, high containment facilities, vacuum systems, centrifuges, dryers and tank farms.
    Pat’s experience covers concept, front end engineering and full project design and implementation and is in demand as a peer reviewer for large API projects.
    Over the last 5 years Pat has been actively engaged in emerging technologies for global pharmaceutical clients. Technologies include nano-milling, continuous reactor design, semi-continuous centrifugation and drying, continuous granulation.

  • Sterile Processing Specialist

    Hugh Hodkinson BE, CEng MIEI, MSc

    Sterile Processing Specialist

    Hugh Hodkinson BE, CEng MIEI, MSc

    Sterile Processing Specialist

    Hugh is a Senior Process Engineer and Technical Specialist with over 15 years’ experience working on a variety of design and commissioning projects in the sterile manufacturing sector. His sterile experience includes vial and syringe fill finish facilities, compounding/ formulation, clean utilities, lyophilisation, filtration systems, isolators/containment and CIP/SIP systems.

    Hugh has published articles on clean utilities for key industry publications such as ISPE Pharmaceutical Engineering and has presented at industry events.

  • Director of Commissioning, Qualification, and Validation

    Jeff Gerstein

    Director of Commissioning, Qualification, and Validation

    Jeff Gerstein

    Director of Commissioning, Qualification, and Validation

    Jeff is the Director of Commissioning, Qualification, and Validation for the DPS Boston, MA USA office. He is responsible for the implementation of all CQV projects and for the growth and development of the firm’s CQV business stream in North America. Jeff brings comprehensive validation, testing, and project engineering experience in many facets of manufacturing operations and facility systems. He has a strong track record working in highly regulated environments in both project management and technical leadership roles, including startup, shutdown, and changeover activities. Additionally, Jeff is highly skilled in developing integrated commissioning and qualification policies and procedures and leading CQV teams for pharmaceutical and biotechnology clients.

  • Lean Construction Systems Consultant

    Richard Casey. B Eng, Lean Green Belt

    Lean Construction Systems Consultant

    Richard Casey. B Eng, Lean Green Belt

    Lean Construction Systems Consultant

    Richard is a Senior Lean Manufacturing and Construction Project Manager with DPS Advanced Technology Group. Richard has over 20 years’ experience in the Semiconductor High Volume Manufacturing and Construction Sectors in Ireland and the US completing Project Management, Project Systems Design and Lean Program Implementation. Richard has significant experience in lean principles implementation of productivity systems and structure for manufacturing and construction as well as extensive experience in developing productivity improvement systems to reduce waste and eliminate impacts from design through to commissioning for large capital projects. Richard’s experience covers all aspects of semiconductor installation from Basebuild, AMHS and Tool Installation. Richard is author of a number of papers on ‘People Development’ and has published his own book on goal setting and problem solving techniques for new managers. Richard has also developed productivity improvement systems such as CTIR (Cycle time interrupt) for improving TPT through manufacturing processes, General Contractor Safety System (GCSS) for optimising safety resources on construction projects and the Daily Milestone tracker (DMT) for tracking and managing large scale project progress.