
Gregg leads the engineering management and execution of capital projects with experience in industrial process control systems, safety management systems, and plant start-up. He brings extensive experience as owner’s representative and design leader in construction, installation and commissioning of automation, equipment and facilities a
Gregg leads the engineering management and execution of capital projects with experience in industrial process control systems, safety management systems, and plant start-up. He brings extensive experience as owner’s representative and design leader in construction, installation and commissioning of automation, equipment and facilities across several industries.
Combining engineering, leadership, and communication skills, Gregg excels at ensuring that large and small complex projects meet and exceed stakeholders' expectations. Gregg has broad industrial experience in chemicals, biologics and food manufacturing; electricity markets, generation, and transmission; upstream and downstream oil and gas.

Phil has over 40 years in engineering management and execution of capital projects. Phil is an experienced and versatile engineering leader with successful roles in capital project delivery, design and commissioning of large-scale fermenters, cell culture process and bio-manufacturing.
He is well-versed in manufacturing facility design to
Phil has over 40 years in engineering management and execution of capital projects. Phil is an experienced and versatile engineering leader with successful roles in capital project delivery, design and commissioning of large-scale fermenters, cell culture process and bio-manufacturing.
He is well-versed in manufacturing facility design to achieve flexibility and reconfigurability. He has substantial bio-manufacturing capital project experience, including large scale fermentation processes for biopharmaceuticals, food, antibiotics and industrial chemical products.
Phil has led design teams for consultancy and capital projects in the US and Europe and brings engineering management skills to deliver safe, high quality and commercially successful outcomes to clients.

With more than 11 years of operating company experience, Barry’s roles have ranged from operator, supervisor, and Project Manager for the development of a topical ophthalmic drug formulation process to Fermentation Manager.
With more than 27 years as a contract process consultant, Barry has been responsible for providing process engineerin
With more than 11 years of operating company experience, Barry’s roles have ranged from operator, supervisor, and Project Manager for the development of a topical ophthalmic drug formulation process to Fermentation Manager.
With more than 27 years as a contract process consultant, Barry has been responsible for providing process engineering assistance to clients in the development, design, commissioning, validation, and operation of biochemical can chemicals processes used in the pharmaceutical and biotech industries.
His roles have ranged from Project Manager for the development of a topical ophthalmic drug formulation process to Fermentation Manager.
Barry is highly experienced with Downstream Processing of Fermentation Cell Culture Products, Fermentation / Cell Culture Processes, GMP Process Systems, Clean in Place systems, and Sterilization In Place.

Andrew is a senior process and project engineer with 14 years of experience in the life sciences industry. He has served as a process engineering lead for biotechnology and pharmaceutical clients, specializing in cleaning and sterilization. He has led GMP equipment installation and construction efforts, often acting as the client’s projec
Andrew is a senior process and project engineer with 14 years of experience in the life sciences industry. He has served as a process engineering lead for biotechnology and pharmaceutical clients, specializing in cleaning and sterilization. He has led GMP equipment installation and construction efforts, often acting as the client’s project manager.
His background includes the design, installation, startup, commissioning, and management of upstream and downstream bioprocess systems. Andrew has served as CIP commissioning lead on both greenfield and expansion projects, and he has overseen technology transfer and new‑product CIP initiatives from design through commissioning. His experience spans multiproduct CDMO fermentation facilities, biologics manufacturing capacity expansions, aseptic fill‑finish startup, and insulin manufacturing CIP design and commissioning.

Over 25 years in engineering management and execution of capital projects. Experienced in industrial automation systems, networking and cybersecurity, safety management systems, and
plant start-up as well as control system development.
Rob is as subject matter expert and design leader in construction, installation and commissioning of auto
Over 25 years in engineering management and execution of capital projects. Experienced in industrial automation systems, networking and cybersecurity, safety management systems, and
plant start-up as well as control system development.
Rob is as subject matter expert and design leader in construction, installation and commissioning of automation systems across several industries. Rob combines broad knowledge and experience with strong communication skills to bridge the gap between hands-on technical execution and executive planning and decision-making. Rob brings industrial experience in pharmaceutical, chemical and auto manufacturing; powerhouse and water treatment; open-die and closed-die forging; offshore oil & gas systems.
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Leonard is a bioprocessing design specialist. Leonard has over 30 years of experience in the biotechnology and food processing industry with 10 years of experience in the field and 1 year of operations experience in a development lab. Leonard has led multiple projects ranging from $280 million to over 1B TIC. Experience includes design an
Leonard is a bioprocessing design specialist. Leonard has over 30 years of experience in the biotechnology and food processing industry with 10 years of experience in the field and 1 year of operations experience in a development lab. Leonard has led multiple projects ranging from $280 million to over 1B TIC. Experience includes design and installation of process equipment, construction support and start-up, operation and troubleshooting of process equipment and control systems.
He has experience in various plant utility system designs, including compressed gases, clean steam, water pretreatment, reverse osmosis, purified water, WFI and solvent distribution. He has experience in process equipment specification, including autoclaves, CIP Skids, purification skids (UF, MF, Virus removal), chromatography skids, WFI and clean steam generation, cGMP washers, sanitary pressure vessels, and coordination of equipment support requirements. Leonard is also experienced in evaluation of secondary containment requirements (per NFPA and CFR regulations) for waste neutralization systems and validation of production-scale fermenters, ultrafiltration skids, WFI systems, HVAC systems and various utilities.
Leonard’s process experience also includes batch scheduling, P&ID development, and coordination of multi-office design execution on various projects.

Doug is a seasoned Process Engineer with nearly 30 years of experience in the pharmaceutical industry. He specializes in equipment engineering, process improvement, project management, and operations. Doug has a background as a process support engineer in the biopharmaceutical industry, where he has executed CAPAs, change control, mainten
Doug is a seasoned Process Engineer with nearly 30 years of experience in the pharmaceutical industry. He specializes in equipment engineering, process improvement, project management, and operations. Doug has a background as a process support engineer in the biopharmaceutical industry, where he has executed CAPAs, change control, maintenance, and qualification activities under GMP regulations. His primary expertise lies in downstream biopharmaceutical operations, including chromatography, TFF, and virus filtration. Doug also has experience with bioreactors, centrifugation, CIP/SIP, and media and buffer preparation and hold systems. He has a strong understanding of safety culture and has been instrumental in ensuring safe operations during multiple facility start-ups.

Maycol is a pharmaceutical engineering professional with over 20 years of progressive experience, specializing in the formulation and filling of sterile injectables, from performing manufacturing tasks to leading teams within the MFG organization.
Maycol’s career evolution includes successful leadership roles, coupled with in-depth techni
Maycol is a pharmaceutical engineering professional with over 20 years of progressive experience, specializing in the formulation and filling of sterile injectables, from performing manufacturing tasks to leading teams within the MFG organization.
Maycol’s career evolution includes successful leadership roles, coupled with in-depth technical experience in individual contributor roles (system and process support). He’s experienced in construction, validation, and regulatory inspection of a fill and finish expansion as well as supporting start-up facilites.

Skye has over 10 years of process engineering experience in the pharmaceutical industry. Skye’s predominant area of expertise is in CIP and SIP circuit and equipment design, integration of CIP and SIP into pharmaceutical processes and automation. She is well-versed in valve manifold, transfer panel, and spray device design, specification,
Skye has over 10 years of process engineering experience in the pharmaceutical industry. Skye’s predominant area of expertise is in CIP and SIP circuit and equipment design, integration of CIP and SIP into pharmaceutical processes and automation. She is well-versed in valve manifold, transfer panel, and spray device design, specification, and acceptance testing. Additionally, she is experienced in the preparation of CIP and SIP functional specifications, functional requirements, testing protocols for CIP/SIP cycle development and performance qualification.
Skye also offers over 6 years of experience in hydraulic modeling of process systems, CIP circuits, and troubleshooting. Skye has served as both the project manager and lead engineer on multiple projects. She strives to become a valuable asset to each client and bring creative solutions to the table.

Benjamin is an engineer with experience in both Process and Automation with an emphasis on automation for the pharmaceutical industry. Ben is a quick learner and excellent problem solver, able to quickly grasp a client’s system, troubleshoot process and automation issues, and develop solutions. With most of his experience in GMP/GDP phar
Benjamin is an engineer with experience in both Process and Automation with an emphasis on automation for the pharmaceutical industry. Ben is a quick learner and excellent problem solver, able to quickly grasp a client’s system, troubleshoot process and automation issues, and develop solutions. With most of his experience in GMP/GDP pharmaceutical environments, he is comfortable working within client’s change control and documentation systems to implement and document improvements.
Ben’s automation experience spans from Fill-Finish systems to automated warehouse projects, and he has worked effectively as part of large commissioning/validation teams and as an individual supporting continuous improvement of systems in production.
His automation skills are reinforced by experience with process engineering, especially for Clean in Place and Steam in Place design. He is skilled in a variety of engineering software including AFT Fathom and Studio 5000 and is a quick learner when picking up new software.

Olivia is a process engineer with over six years' experience in conceptual and detailed design, automation design, and operational validation for large-scale fermentation, chemical and biopharmaceutical manufacturing facilities. She has taken on a wide range of roles and is able to adapt to a variety of environments and situations.
Her e
Olivia is a process engineer with over six years' experience in conceptual and detailed design, automation design, and operational validation for large-scale fermentation, chemical and biopharmaceutical manufacturing facilities. She has taken on a wide range of roles and is able to adapt to a variety of environments and situations.
Her expertise includes CIP and SIP from skid design through circuit development. With her experience in control system design and development, Olivia is invaluable in bridging the gap between process and automation.

Anna is a process engineer with experience in the pharmaceutical industry covering process development through new site construction and commissioning. She has also worked in the oil and gas, industrial minerals, and brewing and distilling industries. Her career has included work on three continents, with roles in commissioning, validatio
Anna is a process engineer with experience in the pharmaceutical industry covering process development through new site construction and commissioning. She has also worked in the oil and gas, industrial minerals, and brewing and distilling industries. Her career has included work on three continents, with roles in commissioning, validation, and project engineering that have honed her ability to adapt quickly to new challenges and draw insights from diverse experiences.
Anna’s expertise lies in CIP skid design, circuit development, commissioning, and validation. Her most recent work includes depth and viral filtration, as well as transfer and utility panels, where she has served as the lead package owner responsible for design, procurement, and commissioning. With a strong “can-do, will-do” attitude, Anna is an invaluable team member in achieving project goals.

With over 30 years of experience and 19 cGMP manufacturing and laboratory facilities under his belt, Alex DeSeabra doesn't just understand pharmaceutical manufacturing—he has helped build its modern landscape. As an entrepreneurial leader and the co-founder of Biofactura, Inc., Alex brings a rare "owner’s perspective" to every project. Wh
With over 30 years of experience and 19 cGMP manufacturing and laboratory facilities under his belt, Alex DeSeabra doesn't just understand pharmaceutical manufacturing—he has helped build its modern landscape. As an entrepreneurial leader and the co-founder of Biofactura, Inc., Alex brings a rare "owner’s perspective" to every project. Whether starting up a new manufacturing venture or navigating the complexities of a million-dollar capital project, his career is defined by a unique ability to bridge the gap between high-level corporate strategy and the rigorous technical demands of the shop floor.
Alex’s technical repertoire is as deep as it is diverse, spanning microbial, mammalian, and autologous cell lines, as well as cutting-edge mRNA technologies. His expertise in Commissioning, Qualification, and Validation (CQV) is evidenced by his leadership on projects. From drafting CMC sections for FDA submissions to troubleshooting RO skids and WFI stills for industry giants, Alex ensures that quality and regulatory compliance (FDA, EMEA, ANVISA) are baked into the process, not just added as an afterthought.
Beyond the cleanroom, Alex is a seasoned global consultant and the founder of DC GMP Pharma Services. Fluent in Portuguese and conversant in Spanish, he has become a go-to specialist for international biopharmaceutical opportunities, particularly in Latin America, where he has led facility designs and regulatory responses for companies. By blending technical mastery in downstream processing and aseptic technique with a Certified Project Manager’s eye for budgeting and revenue recognition, Alex provides the strategic oversight necessary to move life-saving therapeutics from the lab to the patient with precision and speed.

Mike has had a decorated and respected career of progressive growth. As an industrial automation specialist, his 30 years of experience started in the United States Navy as an Aviation Electronics Technician and has led to him to be a subject matter expert with a history of leading world class teams of industrial technicians.
Mike has bee
Mike has had a decorated and respected career of progressive growth. As an industrial automation specialist, his 30 years of experience started in the United States Navy as an Aviation Electronics Technician and has led to him to be a subject matter expert with a history of leading world class teams of industrial technicians.
Mike has been deployed worldwide for his expertise in downtime remediation and disaster recovery and his integration, optimization, and life-cycle extension skills working with legacy technology are outstanding.
He is proficient in multi‑craft process evaluations, delivering practical, technology‑based solutions across diverse industrial environments. Mike is also specialized in design review, FAT/SAT testing, commissioning, debugging, and complex troubleshooting.
In operations and manufacturing, Mike is experienced in conducting operational maintenance health assessments for offshore oil and gas platforms and optimizing sustainability KPIs in continuously controlled industrial processes. He is knowledgeable in distributed control systems (DCS), human‑machine interfaces (HMI), and secure network and remote‑access architecture.
Mike also provides technical training, mentorship, and structured troubleshooting programs, while overseeing vendor and supplier quality. He has a strong track record supporting project startups, commissioning activities, and successful system turn‑overs.

John is a Senior Project Manager & Engineer with 23+ years of experience in the biopharmaceutical industry, specializing in process system design, CIP/SIP/COP systems, automation integration, commissioning & validation, and complex project leadership for major global biotech organizations.
He’s highly experiences in Process & Mechanical De
John is a Senior Project Manager & Engineer with 23+ years of experience in the biopharmaceutical industry, specializing in process system design, CIP/SIP/COP systems, automation integration, commissioning & validation, and complex project leadership for major global biotech organizations.
He’s highly experiences in Process & Mechanical Design, including Hydraulic sizing and design of inline dilution skids, multi‑component mix/formulation skids, and CIP distribution systems; Piping and instrumentation design (P&IDs), valve specification, and control strategy alignment with client and industry standards; and Thermal performance verification of heat exchangers and process utilities.
His Commissioning, Qualification & Validation experience includes Management of validation activities for chromatography, CIP, SIP, and filtration systems; execution of swab tests, SIP tests, and validation procedures using tools such as Kaye validators and Development of validated processes (e.g., pack‑in‑place chromatography column methods).


Andres is an accomplished and results-driving professional with 12 years of experience leading, supporting, and delivering capital projects. He has proven track managing multidisciplinary engineering teams in projects focused on facilities expansion and equipment installation and start-up within the Pharmaceutical and Food and Beverage in
Andres is an accomplished and results-driving professional with 12 years of experience leading, supporting, and delivering capital projects. He has proven track managing multidisciplinary engineering teams in projects focused on facilities expansion and equipment installation and start-up within the Pharmaceutical and Food and Beverage industries.
He has experience in critical and non-critical utilities such as Purified and Water for injection systems and HVAC systems for cleanroom and warehouse humidity and temperature control. Additionally, he has delivered projects involving installation, commissioning and start-up for equipment used in liquid filling, tablet and powder processing, blister packaging, cold-rooms, and warehouse ASRS. He is also well-versed in project financial analysis.
Andres has led capital project teams in South America (Ecuador) and supported projects in the US and holds PMO Certified Practitioner (PMO-CP) certificate issued by the PMI. He is a passionate leader who will work hand in hand with clients in the creation and implementation of best practice manufacturing vision, strategy, processes, and procedures to aid and improve operational performance and deliver adequate return of investment. He currently holds a PMO Certified Practitioner (PMO-CP) certificate issued by PMI.

Chris is a creative biopharmaceutical industry engineer with strong experience in 3D CAD design and project management, contributing to initiatives ranging from full‑cycle new product development to the design and construction of a mobile, semi‑trailer‑based product showcase.
He is skilled across project management, product management, and
Chris is a creative biopharmaceutical industry engineer with strong experience in 3D CAD design and project management, contributing to initiatives ranging from full‑cycle new product development to the design and construction of a mobile, semi‑trailer‑based product showcase.
He is skilled across project management, product management, and project engineering roles, applying a blend of technical expertise, hands‑on problem‑solving, and team leadership.
Chris is proficient in 3D and 2D CAD platforms including AutoCAD, Pro/E Wildfire, and SDRC, with a proven ability to drive cost and lead‑time reductions through process improvements and innovative engineering approaches. He is adept at presenting complex ideas clearly, motivating cross‑functional teams, and utilizing a wide range of tools and equipment to support engineering activities.
Chris is also highly experienced in diagnosing mechanical and hydraulic issues and familiar with both traditional and alternative manufacturing methods, contributing to efficient, reliable, and production‑ready solutions.

Steve is a validation engineer specializing in equipment qualification, deviation management, and commissioning activities for biopharmaceutical manufacturing facilities. With six years of hands‑on experience supporting large‑scale capital projects, Steve brings a strong blend of technical writing, validation expertise, and cross‑function
Steve is a validation engineer specializing in equipment qualification, deviation management, and commissioning activities for biopharmaceutical manufacturing facilities. With six years of hands‑on experience supporting large‑scale capital projects, Steve brings a strong blend of technical writing, validation expertise, and cross‑functional coordination.
He has supported complex commissioning and qualification efforts involving process equipment, warehouse expansions, utilities, and recipe qualification.
Steve’s background includes deep familiarity with GMP cleanroom operations, temperature mapping, and electronic validation management using Kneat. He collaborates closely with process and design engineers to ensure equipment meets required specifications, and he consistently delivers high‑quality turnover packages, protocol documentation, and deviation investigations. His experience spans freezer qualification programs, process system overhauls, SIP cycle qualification, and the commissioning of multi‑system equipment trains.

Said is an adaptive design professional with a technical foundation in additives & digital manufacturing.
Said is a systems technician and highly experienced in CAD design. Working on meticulous review of P&ID's, PFDs, & technical data sheets as well as assisting in procurement of specialized equipment, ensuring precision from conceptual d
Said is an adaptive design professional with a technical foundation in additives & digital manufacturing.
Said is a systems technician and highly experienced in CAD design. Working on meticulous review of P&ID's, PFDs, & technical data sheets as well as assisting in procurement of specialized equipment, ensuring precision from conceptual design to physical systems.
Said brings a unique, High-stakes leadership perspective to the Engineering field rooted in 12 years of experience within the fine dining restaurant industry. Having served as Chef, General Manager, and Owner, he possesses a blend of technical proficiency and executive-level management skills. This background allows Said to navigate the pressure of project deadlines, procurement logistics, and stakeholder interactions with the same composure and communication skills required in a high-volume technical kitchen environment.

Michelle has over 30 years of experience in manufacturing environments performing Project Management, Estimating, Commissioning / Qualification, and Technical/Customer Service assistance.
She has provided on/off site services to Pharmaceutical / Biotech companies, managing logistics, inspections, and documentation related to Commissioning
Michelle has over 30 years of experience in manufacturing environments performing Project Management, Estimating, Commissioning / Qualification, and Technical/Customer Service assistance.
She has provided on/off site services to Pharmaceutical / Biotech companies, managing logistics, inspections, and documentation related to Commissioning/Qualification (Validation) and project turn over package initiatives. This includes support for component/equipment procurement and receipt verification, review/evaluation against design specifications and P&ID’s, providing on site installation verifications (including P&ID, line slope, and weld documentation audits), and Validation document creation and execution.
Michelle’s is highly experienced in components, instruments, and equipment used in the food, beverage, and Pharmaceutical/Biotech industries. She has comprehensive knowledge and experience with engineering specifications and RFQ packages.

Simon is a Computer Engineering graduate from Minnesota State University, Mankato, with hands-on experience in both chemical and pharmaceutical manufacturing environments. He has worked as a Project Engineer and Validation Engineer, supporting digital systems, process documentation, and plant operations in regulated industrial settings.
S
Simon is a Computer Engineering graduate from Minnesota State University, Mankato, with hands-on experience in both chemical and pharmaceutical manufacturing environments. He has worked as a Project Engineer and Validation Engineer, supporting digital systems, process documentation, and plant operations in regulated industrial settings.
Simon has experience as an automation Engineer in an expansion project. He also has worked as a Project Engineer integrating a digital logbook system (eLogger) with a PI Historian for a chemical production plant, supporting operations data capture and process visibility.
He’s experienced in supporting pharmaceutical manufacturing as a Validation Engineer, contributing to CIP validation activities across multiple systems in a regulated environment.
Simon is very knowledgeable in the creating of P&IDs and collaborating with operations, maintenance, and engineering teams to support plant-level projects and system implementations.

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