Senior Biotech Process Engineer — On‑Site Puerto Rico (GMP)

Kelly Services; Juncos (PR); On-site; USD 90,000 - 98,000; Full time

Benefits offered by this job

Bi-Weekly pay (W-2) and holidays paid

Paid vacations & holidays

Christmas bonus

Retirement savings plan

Transit spending account

Job summary

Kelly Engineering in Juncos, PR, is seeking a Senior Process Engineer to drive process optimization, troubleshooting, and validation across commercial manufacturing and packaging operations in a GMP setting.

The role requires experience with sterile injectables and device packaging, strong cross‑functional collaboration, and bilingual English/Spanish communication to support regulatory and quality systems. On‑site, 8‑hour shifts with flexible hours.

Qualifications

• Master’s degree in Engineering with 2+ years experience or Bachelor’s degree in Engineering with 4+ years experience in pharmaceutical/biotech/manufacturing operations.
• Experience managing engineering projects and leading cross-functional initiatives across Manufacturing, Quality, Validation, Maintenance, Automation, Supply Chain, and Regulatory Affairs.
• Hands-on experience with sterile injectable products and packaging operations (labeling, cartoning, inspection, packaging‑line troubleshooting).
• Expertise in process investigations, root cause analysis, validation activities, GMP compliance, and quality‑system processes including deviations, CAPAs, change controls, and nonconformances.
• Strong technical writing, data analysis, problem-solving; experience drafting reports, protocols, risk assessments, investigations, and engineering documentation.
• Strong written and verbal communication in English and Spanish

Responsibilities

• Lead process optimization, troubleshooting, validation, and engineering initiatives supporting commercial manufacturing, packaging, and combination-product operations in a GMP environment.
• Apply advanced engineering principles to resolve complex technical issues and implement equipment improvements.
• Manage projects and support qualification and validation activities to ensure compliance and quality.
• Collaborate across functions to investigate deviations, analyze performance, and drive continuous improvement.

Skills

Engineering management

Cross-functional collaboration

Process validation

GMP compliance

Technical writing

English & Spanish

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering

Job description

Kelly Engineering in Juncos, PR, is seeking a Senior Process Engineer to drive process optimization, troubleshooting, and validation across commercial manufacturing and packaging operations in a GMP setting.

The role requires experience with sterile injectables and device packaging, strong cross‑functional collaboration, and bilingual English/Spanish communication to support regulatory and quality systems. On‑site, 8‑hour shifts with flexible hours.