Equipment SME Consultant

FITS LLC; Wilson (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Excellent customer service

Job summary

FITS LLC is seeking an experienced Biopharma Equipment SME to join our team in the United States. The role focuses on supporting biopharmaceutical manufacturing equipment, ensuring qualification, commissioning and validation activities are conducted to meet regulatory standards.

Ideal candidates have a Life Science or Engineering degree, bilingual Spanish-English, plus strong documentation skills and proficiency with MS Office.

Qualifications

• Bachelor’s Degree in Life Science or Engineering with exposure to Validation Life Cycle in Pharma.
• Bilingual (Spanish & English).
• Shift: Administrative, and according to business needs.
• Proficient writing in English and strong MS Office skills.
• Experience with biopharmaceutical manufacturing equipment.
• Strong understanding of pharma manufacturing processes, equipment needs and cGMP.
• Expertise with equipment qualification, commissioning and validation.

Responsibilities

• Serve as a technical SME for biopharmaceutical manufacturing equipment.
• Provide guidance on equipment selection, specs, functionality and performance.
• Support equipment evaluations, troubleshooting, and problem-solving.
• Collaborate with Engineering, PM, Manufacturing and cross-functional teams.
• Ensure activities align with cGMP, quality standards, and site procedures.
• Support equipment documentation and project deliverables.
• Assist with equipment commissioning, qualification and validation as needed.
• Identify equipment risks and develop technical solutions.

Skills

Bilingual Spanish-English

Documentation (English)

biopharma equipment

cGMP knowledge

Equipment Validation

Education

Bachelor's Degree in Life Science or Engineering

Tools

MS Office

Job description

Biopharma Equipment SME services.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Life Science or Engineering, andpreviousyears of exposure in Validation Life Cycle within the Pharmaceutical Industry.
• Bilingual (Spanish & English)
• Shift: Administrative, and according to business needs.
• Good skills in writing general documentation in English and using MS Office applications.
• Experience in:
• 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.

The Personality Part:

• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). 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.
• 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.
• Assist with identifying equipment-related risks and developing appropriate technical solutions.

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!

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent. We're FITS!