Equipment SME Consultant

​ For Biopharma Equipment SME services.

About Flexible & Integrated Technical Services, LLC

It means you’re creative, with such an eye for detail that nothing gets past you.

If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job): Serve as a technical Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment.

BEING A FITS PIECE COMES WITH PERKS: One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed).

However, that’s not all we have to offer.

Talk with us to find out!

We are a Service Provider company different from the rest.

We pride ourselves in how we treat the most important piece of our company's puzzle: you!

We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).

Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.

We're FITS!

Are you the Next Piece? ​

Responsibilities

• The Technical Part: Bachelor’s Degree in Life Science or Engineering, and previous years of exposure in Validation Life Cycle within the Pharmaceutical Industry.
• Administrative, and according to business needs.
• Good skills in writing general documentation in English and using MS Office applications.
• Provide technical guidance on equipment selection, specifications, functionality, and performance.
• Support equipment evaluations, troubleshooting, and technical problem-solving.
• Collaborate with Engineering, Project Management, Manufacturing, and other cross-functional teams to support equipment-related activities.
• Ensure equipment-related activities align with applicable cGMP requirements, quality standards, and site procedures.
• Provide technical input and support for equipment documentation and project deliverables.
• Support equipment commissioning, qualification, and validation activities as needed.

Requirements

• Proven experience with biopharmaceutical manufacturing equipment within the pharmaceutical or biotechnology industry.
• Strong understanding of pharmaceutical manufacturing processes, equipment requirements, and applicable cGMP regulations.
• Strong expertise with equipment qualification, commissioning, and validation activities.
• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course).

Preferred

• Assist with identifying equipment-related risks and developing appropriate technical solutions.