Bilingual Pharma Process Engineer – cGMP & CAPA Focus

Kelly Services; Juncos (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

KellyScience, Engineering, Technology & Telecom (SETT) seeks an Engineer to work in the PR region. The role involves process optimization and troubleshooting in manufacturing environments, with non-standard shifts possibly required.

Ideal candidates hold an Engineering degree (Master’s or Bachelor’s with experience) and have strong knowledge of GDP, CAPA, and cGMP procedures, plus system ownership experience.

Qualifications

• Master’s degree in Engineering or Bachelor’s degree with 2 years of Engineering experience.
• Experience with cGMP procedures in pharma/biotech production.
• Experience with process characterization, validation, monitoring, and optimization; CAPAs.
• GDP knowledge and documentation practices.
• System Owner experience; MMP experience.
• Bilingual Spanish and English.
• Availability to work non-standard shifts.

Responsibilities

• Characterize process optimization strategies and troubleshoot operational issues in manufacturing, pilot plant, or capital projects environments.
• Apply basic engineering principles to design and implement system modifications, experiments, or capital projects.
• Organize, analyze, and present interpretation of results for issues or minor projects.

Skills

Process optimization

Root cause analysis

CAPA management

GDP knowledge

cGMP procedures

Documentation control

Bilingual Spanish/English

Education

Master's degree in Engineering

Bachelor's degree in Engineering

Job description

KellyScience, Engineering, Technology & Telecom (SETT) seeks an Engineer to work in the PR region. The role involves process optimization and troubleshooting in manufacturing environments, with non-standard shifts possibly required.

Ideal candidates hold an Engineering degree (Master’s or Bachelor’s with experience) and have strong knowledge of GDP, CAPA, and cGMP procedures, plus system ownership experience.