Process Engineer – Manufacturing & Validation

About the role

We are looking for a dedicated Engineer to support process optimization, troubleshooting, and capital projects within a regulated pharmaceutical and biotech environment. The role operates under general supervision and contributes to both operational and design activities.

Key responsibilities

• Characterize process optimization strategies and troubleshoot operational issues in manufacturing, pilot plant, or capital projects.
• Apply basic engineering principles to design and implement system modifications, experiments, and minor‑scope projects.
• Analyze results, prepare interpretations, and present findings for operational or engineering issues.
• Audit equipment performance and regulatory compliance, and collaborate with research, manufacturing, maintenance, quality, and validation teams.
• Support design engineering tasks, work with consultants and architects, obtain and critique equipment quotes, and generate preliminary cost estimates and schedules.

Required profile

• Bachelor's degree in Engineering.
• Minimum 2 years of engineering experience, preferably in a regulated environment.
• Experience with equipment and process troubleshooting in pharmaceutical/biotech settings.
• Knowledge of GMP production operations.
• Strong organizational, technical writing, and presentation skills.
• Fluent communication in English and Spanish.

Required skills

• Equipment troubleshooting
• Process troubleshooting
• GMP knowledge
• Technical writing
• Presentation and communication (English & Spanish)

What we offer

• Opportunity to work with cross‑functional teams on impactful projects.
• Professional growth in a collaborative, ethics‑driven environment.