contact@talentwrx.com    |   1646 W. Snow Ave, Tampa, FL 33606 

Kate Michele Design, 2019

TalentWRx ENGINEERING

TalentWRx specialists deliver in-depth expertise for a complete portfolio of engineering consulting services to pharmaceutical, biotechnology and medical device companies. These services include cutting edge industry standards and experienced consultants for managed turnkey solutions.

 

Our reputation in the Life Sciences market is built on a proven track record among our customers and consultants across this range of services. Our engagement teams work in close alignment with our customers to drive growth, manage risk, and accelerate customer success.

 

Engineering, Design, Build, and Construction
Our involvement ranges from building systems automation, project management, scheduling/planning, cost planning, and process. We also provide engineering consultants to green field facilities and expansion project construction teams for biotech, pharmaceutical, and medical device operations. Our consultants are experienced with sensitive demands on cost, quality, and on time delivery.

 

Validation
As a leading provider of validation consultants, we understand the complexities within Life Sciences and possess the in-depth knowledge and expertise to deliver innovative solutions. Our primary areas of focus include PAT, critical process parameters, process ranges and critical process components. While performing process validation, an intimate understanding of what the process is designed to do and how that process is affected by changes to various components is essential to successful project completion. This understanding better positions TalentWRx to augment a synchronized validation team.

 

Product Design & Development
Our engineering consultants are key contributors to medical device manufacturers bringing products to market quickly and affordably per FDA/CE regulatory requirements. We staff engineers experienced in the Development and Engineering of Class 1, Class 2, and class 3 implantable devices, injection molded, plastic disposable device design, packaging, prototyping and manufacturing, designers of medical device housing and stylistic, industrial designing via 3D computer modeling, electro-mechanical instrument design, and prototype development and fabrication.

 

Commissioning & Qualification
TalentWRx experience includes qualifying equipment encompassing the manufacture of GXP products and complete facility qualifications. Customers depend on us to provide engineering studies for existing equipment, commissioning studies, and a wide range of process qualification. We follow customer guidelines while working to ensure all equipment and systems meet User and Function Requirement Specifications. These criteria, as well as any industry best practices, form the framework for our overall qualification engagements.

 

Manufacturing & Quality Assurance
Biologics continue to be a growing portion of our core businesses. TalentWRx provides the skilled manufacturing resources to drive your production efforts. From testing raw materials to preparing for internal and external audits, our resources ensure the quality of our clients' most important products.

OUR SERVICES

  • Consulting
    Gain access to experienced engineering professionals for project, short- and long-term staffing requirements.

  • Consultant-to-hire
    Evaluate prospective employees on-the-job before committing to a hiring decision.

  • Direct Hire
    Stay focused on your core competencies while TalentWRx recruits and screens candidates on your behalf. Only the most qualified candidates will be referred to you for final evaluation.

 

AREAS OF EXPERTISE: 

Engineering

  • BAS

  • Automated Systems Design

  • PLC

  • Integration

  • Test Execution & Maintenance

 

Design, Build, and Construction

  • Cost control & Cost Engineering

  • Project controls

  • Scheduler/Planner

 

Validation

  • Automation Systems

  • Computer Systems

  • Cleaning

  • Mechanical

  • Equipment & Utilities

  • Process

  • Chemical

  • Electrical and Instrumentation & Controls

  • Laboratory Instrumentation

 

Product Design & Development

  • Device Design

  • Electrical, Mechanical, and Software

  • Process Design

 

Commissioning & Qualification

  • Qualification protocol preparation IQ/OQ/PQ

  • Qualification execution and report preparation

  • Start-up

 

Manufacturing & Quality Assurance

  • Maintenance and Troubleshooting

  • Packaging

  • Process Improvements & Sustaining

  • cGMP Compliance

  • Systems Audit

  • Consent Decree