Biotech Manufacturing Process Specialist

Inteldot; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Inteldot is seeking an individual for the Administrative Shift in Puerto Rico. This position involves supporting the execution of manufacturing and quality systems while ensuring compliance with GMP standards.

Candidates should have a strong background in biotechnology process support and experience in manufacturing operations. Key responsibilities include managing change controls, conducting deviation investigations, and leading training efforts. A competitive educational background with relevant experience is highly desired.

Qualifications

• Strong expertise in biotechnology pharmaceutical process support, particularly on Drug Substance processes.
• Knowledge in manufacturing operations systems and compliance.
• Ability to lead investigations and provide training.

Responsibilities

• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations including Root Cause Analysis.
• Coordinate and support execution of functional tests and water tests.
• Assess process performance and implement process improvement solutions.

Skills

Biotechnology pharmaceutical process support

GMP pharmaceutical manufacturing systems

SAP

TrackWise

Electronic batch records (PAS/X)

Documents management systems (Veeva)

Education

Masters + 2 years of Manufacturing Operations experience

Bachelors + 4 years of Manufacturing Operations experience

Associates + 8 years of Manufacturing Operations experience

High school/GED + 10 years of Manufacturing Operations experience

Job description

Inteldot is seeking an individual for the Administrative Shift in Puerto Rico. This position involves supporting the execution of manufacturing and quality systems while ensuring compliance with GMP standards.

Candidates should have a strong background in biotechnology process support and experience in manufacturing operations. Key responsibilities include managing change controls, conducting deviation investigations, and leading training efforts. A competitive educational background with relevant experience is highly desired.