With in-house resources, we 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)

Procurement

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

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