Equipment SME Consultant

Flexible & Integrated Technical Services, LLC • Wilson, NC

13d

About The Position

The Equipment SME Consultant serves as a technical subject matter expert for biopharmaceutical manufacturing equipment. The role provides guidance on equipment selection, specifications, functionality, and performance, and supports equipment evaluations, troubleshooting, and technical problem-solving. The consultant collaborates with Engineering, Project Management, Manufacturing, and other cross-functional teams to support equipment-related activities. The position also provides technical input for equipment documentation and project deliverables and supports commissioning, qualification, and validation activities as needed. Equipment-related work must align with applicable cGMP requirements, quality standards, and site procedures. The role helps identify equipment-related risks and develop appropriate technical solutions. The shift is administrative and may vary according to business needs.

Requirements

• Bachelor’s degree in Life Science or Engineering.
• Previous exposure to the validation life cycle within the pharmaceutical industry.
• Bilingual in Spanish and English.
• Good English writing skills for general documentation.
• Proficiency using MS Office applications.
• 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 in equipment qualification, commissioning, and validation activities.
• Self-motivation, curiosity, creativity, and attention to detail.
• Commitment to serving customers with high-quality research and products, embracing a diverse work culture, and caring for the environment.

Responsibilities

• Serve as a technical subject matter expert 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 on 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.

Benefits

• The company describes its customer service as excellent and unmatched.
• The company emphasizes flexibility, a family-oriented culture, and employee well-being.

What This Job Offers

• Job Type: Full-time