Biopharma Equipment SME - Validation & Commissioning Expert

FITS LLC; Wilson (NC); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Excellent customer service

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Bilingual Spanish-English

Documentation (English)

biopharma equipment

cGMP knowledge

Equipment Validation

Ausbildung

Bachelor's Degree in Life Science or Engineering

Tools

MS Office

Jobbeschreibung

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.