Senior Process Engineer - Biotech GMP & Optimization

PharmaLex; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision care

Backup dependent care

Family building support

Paid parental leave

Job summary

PharmaLex in Juncos, Puerto Rico is seeking an engineer skilled in process optimization and troubleshooting to drive manufacturing improvements. Candidates should have significant engineering experience and a strong understanding of bio-processing.

The role involves performing assessments, leading investigations, and ensuring compliance with regulations. A Doctorate or Masters with relevant engineering experience is preferred. The company offers an array of comprehensive benefits.

Qualifications

• In-depth experience of bio-processing unit operations is essential.
• Proficiency in GDP in a regulated environment is required.
• Strong technical writing and communication skills in English and Spanish are necessary.

Responsibilities

• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations.
• Design and support execution of functional tests during major changes.

Skills

Pharmaceutical/biotech processes

Validation processes

Documentation in regulated environment

Problem solving

Technical report writing

Verbal communication

Education

Doctorate or Masters + 2 years of Engineering experience

Bachelors in Engineering + 4 years of Engineering experience

Tools

Trackwise

Spotfire

CDOCS

Job description

PharmaLex in Juncos, Puerto Rico is seeking an engineer skilled in process optimization and troubleshooting to drive manufacturing improvements. Candidates should have significant engineering experience and a strong understanding of bio-processing.

The role involves performing assessments, leading investigations, and ensuring compliance with regulations. A Doctorate or Masters with relevant engineering experience is preferred. The company offers an array of comprehensive benefits.