Life Science Engineering Services

Overview

Trusted design and engineering support for the pharmaceutical, medical device, and biopharmaceutical industries.

Our integrated team includes engineers, technicians, commissioning/validation specialists, and project managers dedicated to providing design and engineering solutions for the life sciences industry. We understand the sensitive nature of life science product development, manufacturing, and packaging and the impact of speed-to-market for the bottom line.

We serve many of the top 10 biopharmaceutical companies in the world. Our life science design and engineering projects include manufacturing processes and facilities, research facilities, R&D/QA labs, and pilot plants. In addition, we have over 50 years of FDA and cGMP experience.

Sterling Engineering is a certified woman-owned business with a dedicated team of experienced, multi-disciplined project managers, engineers, and designers led by a licensed Professional Engineer (PE). Because we have decades of experience working on complex, highly technical projects across various life science clients, we have streamlined our processes, best practices, and customization of manufacturing systems to meet your standards- saving you time and money.

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Sterling engineering capabilities

Sterling Engineering helps pharmaceutical, medical device, and biopharmaceutical companies with design and engineering services…

  • by providing accessibility to an internal team of industry experts without the internal costs of onboarding – accelerating the time to market and shortening the learning curve for complex needs.
  • by limiting project risk with our extensive knowledge of regulatory requirements.
  • by providing oversight on your critical projects.
  • by offering a senior leadership team that understands first-hand the life sciences environment and your needs with 50+ combined years of direct experience working for global manufacturers like yours.
  • by providing a unique depth of service offering to manage the project experience from front-end planning through validation.
  • by delivering on partnerships with internal and external project resources.
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Specialized Skill Sets for the Life Science Industry

  • Asset Management
  • Calibration/Metrology
  • cGMP & QA/QC
  • Commissioning, Validation, Qualification (CVQ)
  • Controls and Instrumentation
  • Equipment Specification and Installation
  • Facility/Utility Engineering
  • Feasibility Assessments & Conceptual Design
  • Front-End Planning, Estimating, and Capital Requests
  • Master Planning
  • Preventive Maintenance Systems
  • Process Engineering
  • Project Management and Project Engineering
engineering solutions for a medical syringe company
engineering and design solutions for life science industry bottle on conveyor belt

Life Science Project Types

  • Biologics
  • Bulk/API Process Equipment
  • Calibration & Metrology
  • Capital Planning
  • Combination Products
  • Commissioning & Qualification
  • Distribution & Logistics
  • Equipment Design
  • Manufacturing Plants
  • Potent Drug Handling
  • Process Development
  • Quality Assurance
  • R&D Labs & Facilities

PROJECT LIFE CYCLE

End-to-end project delivery or a la carte services support all engineering and manufacturing stages.

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Strategy

Front-end planning
Capital investment and ROI assessment
Industry and competitive benchmarking
Strategic alignment and management
Business case assessment
Production loading assessment
Site master planning
Cost-estimating

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Project Management

Assemble cross-functional teams
Custom in-house or offsite solutions
Change management
Project controls
Owner’s representation
Construction management
Bid preparation
Generate project scope documents

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product engineering

Product Engineering

Concepting
Product development
Simulation
Design for manufacturability
Detailing
Reverse engineering
Materials selection
Prototyping

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process engineering

Process Engineering

Engineering methodology
Equipment and plant layout
Process automation assessment & optimization
Industrial engineering
Facilities systems
Production line design & integration
Continuous improvement
Manufacturing support & vendor selection

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equipment engineering

Equipment Engineering

Automated test systems
Robotic work cell systems
Customized equipment design
Assembly fixtures and tooling
Reverse engineering
Detailing (parts, assemblies, and BOM)
Equipment integration

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Start-Up & Documentation

Facility/utility commissioning
Validation/qualification documentation
Quality system documentation
Document control/CAD data
Safety procedures
Operating/maintenance manuals
Instructional design

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Did you know Sterling also provides workforce solutions for the life science industry?

Sterling Staffing has decades of job placement experience, including working with companies within the life science industry. Learn more >

‘Preferred Vendor’

Sterling Engineering, Inc was awarded ‘Preferred Vendor Status’ by a Top Ten Global Pharmaceutical company in recognition of our comprehensive cGMP expertise that ensures risk mitigation and quality outcomes.

As a trusted partner since 1969, our team has the necessary experience to navigate this FDA regulated industry and reduce risk.

Proven solutions for life sciences leaders and innovators.

Contact Sterling to access our deep, industry-specific knowledge.

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