We utilize in-house resources and seamlessly leverage strategic partnerships to provide the most cost-effective solution to your project needs. You can be assured that the support is right-sized and only has team members absolutely critical to delivering your project needs.

Project Management

Managing the project from Initiation and Charter Development all the way through Closeout to ensure your business drivers are met within budgetary and schedule constraints

Services Include

  • Assistance in developing technical approach and business case, analyzing options, securing funding, and identifying implementation resources

  • Overall development and tracking/control of project scope, schedule, and budget

  • Project execution plan development

  • Progress tracking/reporting tools including Earned Value Analysis (EVA) and resource-loaded schedules

  • Coordination of both local and remote multi-disciplinary project teams using the latest IT interfaces

  • Change control management

  • Project/product quality management

  • LEAN/Six Sigma/Agile approaches

Representative Projects

  • Complete pilot and full-scale pharma manufacturing facility build-out

  • Expansion and renovations of microbial/ mammalian and cell/gene therapy biotech manufacturing facilities

  • Oral solid dosage manufacturing & packaging facility renovations

  • Detailed design of specialized pharmaceutical equipment, including reactors, filters, TFF skids, chromatography columns, dryers, and fill/finish equipment

  • Process clean utility systems (USP PW, WFI, Clean Steam, Process Air, Vacuum)

  • Other Process Utilities (Steam, Chilled Water, Heating Hot Oil, Dust Collection)

  • Laboratory and office space build-outs

  • CO2 capture from electrical plant stack emissions

  • Wastewater treatment plant upgrades

Process and Project Engineering

Engineering to support Conceptual Design through Detailed Design, Construction, as well as Full Commissioning & Qualification. Utilizing both in-house resources and strategic partnerships, we offer the full gamut of engineering services (Process, Architectural, Mechanical, Electrical, Instrumentation/Controls, Civil/Structural, and Environmental)

Services Include

  • Facility fit analysis and siting/location due diligence support

  • GMP facility architectural layout design and personnel, material, and waste flows

  • GMP laboratory layout and design

  • Grade A - D GMP space design (clean rooms)

  • GMP HVAC air cascade and dP design

  • Feasibility studies / conceptual design

  • Detailed design and equipment specification including:

    • generation of piping & instrumentation diagrams (P&IDs)

    • equipment and instrumentation specifications

    • equipment and instrumentation data sheets

    • computer-aided design (CAD)

    • operational procedures

    • preventative maintenance (PM) plans

    • spare parts assessments

  • Procurement support and expediting

  • Factory or site acceptance testing for equipment

  • Construction coordination and management

  • Risk-based Commissioning & Qualification (C&Q)

  • Existing process scale-up

  • Existing process optimization using Six Sigma

  • Process development support, including:

    • mass balances & process flow diagrams (PFDs)

    • testing protocols

    • data collection and laboratory analysis

Representative Projects

  • Pharmaceutical equipment & controls system installations ($5K to $20M)

  • New product introductions & launches

  • Innovative carbon capture technology demonstration

  • Oral solid dosage facility material and personnel flow improvements

  • Raw material, in-process, and finished-product material handling project for API manufacturing facility

  • Pharmaceutical packaging line improvements

Process Development and Engineering

Process development and engineering support for new projects, trouble shooting and solutions for existing processes and unit operations. We can provide process development engineering from initial concept and laboratory demonstration to technology transfer into full scale manufacturing and start up support.

Services Include

  • Troubleshooting and problem solving for equipment, processes, and work flow

  • Optimization and scale-up of existing processes, including evaluations of cycle time, yield, quality, and unit operations

  • Statistical assessments

  • Procedures for manufacturing operations and equipment cleaning to meet requirements of manufacturing, quality, regulatory, environmental, safety, and industrial hygiene

  • Feasibility studies / conceptual design / facility fit

  • Analysis of throughput in multiple plants or same-site train locations

  • Mass & energy balances, process flow diagrams (PFDs), and piping & instrumentation diagram (P&ID) development

  • Technology transfer and start-up support from lab to pilot to large scale

  • Hands-on and research-based engineering development at laboratory scale for reactions, actual mass balances, and unit operations including:

  • raw material handling and charging

  • reactions and separations

  • final product isolation & packaging

  • Support for in-house development, including testing protocols, data collection and laboratory analysis

  • Documentation support for regulatory filings for new drug applications (NDA)

Representative Projects

  • Filtration optimization to improve full scale yield worth $1.7M annually

  • Innovative material handling procedure to reduce project cost by $2.4M and reduce operator exposure of highly hazardous product (presented at ISPE)

  • $500K reduction in project cost through statistical data analysis

  • Design and implementation of solvent recovery to increase recovery by 18% (worth $2.3M/month)

Process Control and Automation Services

Vista Engineering is pleased to offer Process Control and Automation Services as part of their overall services provided. The following Process Control and Automation Services are highlighted below:

Services Include

Automation Services:

  • Network Architecture Design and Implementation

  • SCADA Design and Implementation

  • PLC Design and Implementation

  • Data Historian Design and Implementation

Platforms Covered:

  • Rockwell Software Products

  • Siemens

  • Emerson DeltaV

  • Proficy HMI/SCADA

  • Proficy Historian

  • OSI PI Historian

Industries Served:

  • Pharmaceuticals and Biotechnology

  • Material Handling

  • Food and Beverage

Representative Projects

  • Biotech facility business and process controls architecture and infrastructure installation and validation

  • PLC system design, installation, and startup for plant ammonia system

  • DeltaV programming improvements of existing brewing operations

EH&S and Regulatory

We can provide a wide range of environmental, health and safety, and quality services to support both project design and ongoing facility operational needs. We can provide regulatory compliance support including development of compliance programs, environmental permitting, process hazard analysis, pollution prevention, and Current Good Manufacturing Practices (cGMPs).

Services Include

  • Regulatory compliance systems and procedures

  • Waste minimization and pollution prevention programs

  • Air emissions estimation and facility permitting

  • Wastewater and stormwater management and permitting

  • Hazardous and industrial waste management

  • Incident investigation

  • Process hazards analysis

  • Process safety evaluation

  • Utility system recommissioning for energy savings and emission reductions

  • Food and Drug Administration (FDA) audit support and responses

  • Corrective Action/ Preventative Action (CAPA) identification and implementation

  • Emergency Response and Community Right-to-know Act (EPCRA) reporting

  • Leak detection and repair (LDAR) programs

  • Hazardous waste storage tank certification (RCRA Subpart J)

Representative Projects

  • Development of compliance programs for new air emissions regulations specific to pharmaceutical operations

  • Renegotiation of air permit to increase operational flexibility for API manufacturing facility

  • Wastewater and stormwater permitting for start-up API manufacturing facility

  • Energy efficiency improvements for multi-building biopharma manufacturing campus via HVAC system recommissioning

  • Audit of air emission compliance, including corrective actions, for manufacturing facility

  • FDA audit response for oral solid dosage facility

Owner Support

Providing Owner Support during project implementation, we serve as a liaison between your contracted Architectural/Engineering Team and/or Construction Contractors and you as the Owner to protect your project quality and financial interests. In this role, we operate as a true extension of your team, keeping your interests as our #1 priority and seamlessly integrating into your existing systems and infrastructure. We can provide any of our core services direct to your internal organization for either short-term or long-term assignments.

Services Include

  • Internal staff augmentation (Project Management, Process/Project Engineering, Process Development, EH&S, Procurement, Construction Management, Commissioning & Qualification)

  • Technical review of contractor deliverables on Client's behalf, including construction submittals and Requests For Information (RFIs)

  • Support pharmaceutical equipment Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) on Client's behalf

  • Independent Large Capital Project and Site Project Portfolio controls and metrics reporting and project status reporting to Client Management Team

  • Independent 3rd party project due diligence assessment

  • Independent 3rd party cost and schedule estimating

  • Oversight of contractors working onsite at your facility

  • Overall quality inspection of work products (engineering and/or construction)

  • Regulatory audit response support, change control management, corrective action and preventative action closeout

  • Cost-effective support for start-up companies and contract manufacturing companies

Representative Projects

  • Technical support for $30M greenfield cell/gene therapy manufacturing facility design, construction, & startup

  • Commissioning & Qualification Manager for a $20M biopharma facility renovation (Owner's Rep)

  • Technical support for $300M biopharma facility build-out (Owner's Rep)

  • Ongoing environmental compliance support for a pharmaceutical client (Staff Augmentation)

  • Project Management / Process Engineering for an API contract manufacturer (Staff Augmentation)

  • Ongoing Process Development support for an API manufacturing facility (Staff Augmentation)


We can provide assistance to source equipment, materials, technical expertise services, and construction services either using a client's internal procurement systems or through direct-purchase, providing a single invoice to Client.

Services Include

  • Development of Request for Quotations (RFQs)

  • Preparation of bid tabulation

  • Vendor audits, contracts, and negotiation of payment terms

  • Purchase Orders (POs) issuance and management

  • Vendor invoice and payment processing

  • Expediting and purchase status tracking

  • Change Order (CO) processing

Representative Projects

  • Procurement of $2M API Pilot Plant equipment and construction services

  • Ongoing Biotech manufacturing facility material, equipment and services procuremen

Turnkey Project Execution

In addition to standard engineering, procurement, and construction management services, we have strategic partnerships with top-rated construction/implementation contractors to enable us to provide turnkey project execution from up-front planning through closeout (cradle to grave).

Services Include

  • Facility Architectural/Mechanical/Electrical retrofits

  • GMP Tenant Improvements

  • Greenfield facility installation

  • Process/Manufacturing equipment installations/retrofits

  • Up-front prospective facility space due diligence all the way through system startup and Commissioning/Qualification

Representative Projects

  • $4M Sterile Fill/Finish facility build-out

  • $10M API pilot plant and production facility build-out

  • $300K Quality Control (QC) Laboratory design and build-out

  • $200K Process Development Laboratory design and build-out