Manufacturing, Engineering, Commissioning/Qualification & Validation

Power your manufacturing, engineering, commissioning/qualification, and validation operations with experienced life science specialists. Fill internal gaps or target a specific role with an individual resource or team to see your project or program through to success on time and on budget. We provide you with support no matter which phase your project is in.

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Manufacturing

Our specialists can evaluate and enhance any link in your manufacturing operations from material receipt to finished product distribution.

  • Product & Personnel Controls

  • Aseptic Processing

  • Biologics Manufacturing

  • Product Assembly

  • Packaging & Labeling

  • Process Optimization

  • Sterilization

  • Lyophilization

  • Purification

Engineering

Our staff of engineering specialists span across multiple disciplines to ensure your needs are met. Whether you need to implement a global document control system or develop a package for your product we have the expertise to assist you.

  • Software Engineering
    • System Migration
    • Imbedded Device Software
    • Testing
    • Instrument and Device
  • Commissioning and Qualification
    • Equipment
    • Utilities
    • Facilities
    • Factory Acceptance Testing
  • Product, Process and Equipment Engineering
    • Design Engineering
    • Product Development
    • Manufacturing Process Engineering
    • Packaging Engineering
    • Instrument and Control
  • Turn Key Project Management
    • Project Conception and Feasibility
    • Project Management
    • Project Delivery

Commissioning/Qualification & Validation

We work with our clients to develop scalable resource plans to support validation efforts throughout the project lifecycle. Whether it is drafting protocols to execution and compilation of data packs our experts have you covered.

  • Master Validation Plans (MVPs)

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Equipment Validation

  • Software Validation

  • Process Validation

Our resources can be utilized to meet the wide range of quality and compliance requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about fulfilling specific manufacturing, engineering, commissioning/qualification, and validation staffing needs. We help clients secure a wide variety of life science specialists with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.

Why work with The FDA Group?

  • Get quick, easy access to industry resources.

  • Fulfill short or long-term staffing needs at a competitive rate.

  • Get a flexible alternative to traditional full-time hiring.

  • Receive dedicated project management and a Total Quality Guarantee.

Brochure Learn more about our staff augmentation services.

Read our brochure to learn more about staff augmentation and our full range of life science resourcing capabilities.

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Contact us today to learn more about our manufacturing, engineering, commissioning/qualification & validation staff augmentation services.