Senior Biotech Process Engineer — GMP & Validation

Inteldot; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Inteldot is looking for an Administrative Shift Engineer in Puerto Rico. The role involves providing and directing process optimization strategies and troubleshooting in various operational environments, applying diverse engineering principles.

Candidates should have significant experience in biotechnology pharmaceutical processing, knowledge in GMP systems, and technical skills in SAP and electronic batch records. A Doctorate or relevant engineering experience is required.

Qualifications

• Experience in biotechnology pharmaceutical process support, especially on Drug Substance processes.
• Familiarity with validation processes in a highly regulated environment.

Responsibilities

• Complete complex or novel assignments requiring development of new engineering techniques.
• Develop engineering policies affecting multiple organizational units.
• Coordinate and review work of a small staff of engineers and technicians.
• Employ advanced engineering techniques within area of expertise.
• Work with project managers to complete design and engineering projects.

Skills

Biotechnology pharmaceutical process support

GMP pharmaceutical manufacturing systems

SAP

Technical writing and verbal communication

Education

Doctorate or Masters + 2 years of Engineering experience

Bachelor’s in engineering + 4 years of Engineering experience

Tools

TrackWise

Electronic batch records (PAS/X)

Documents management systems (Veeva)

Job description

Inteldot is looking for an Administrative Shift Engineer in Puerto Rico. The role involves providing and directing process optimization strategies and troubleshooting in various operational environments, applying diverse engineering principles.

Candidates should have significant experience in biotechnology pharmaceutical processing, knowledge in GMP systems, and technical skills in SAP and electronic batch records. A Doctorate or relevant engineering experience is required.