Pharma Process Engineer (24/12 Shifts) – GMP/GLP Focus

Quality Consulting Group, LLC; Juncos (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Quality Consulting Group, LLC seeks a talented engineer to support daily manufacturing operations in a regulated biotech/pharma environment in Puerto Rico and the US. You will troubleshoot processes, optimize operations, and participate in deviations, qualifications, and capital projects.

The role requires a Bachelor’s in Engineering (Chemical preferred), strong data analysis, and experience with GMP/GLP documentation. Flexibility for non-standard hours may be needed.

Qualifikationen

• Bachelor’s degree in Engineering (Chemical Engineering preferred).
• Experience in biotech companies would be a plus.
• Drug substance manufacturing/technical support would be a plus.
• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes and documentation in a regulated environment.

Aufgaben

• Provide technical engineering support to daily manufacturing operations, including troubleshooting, process optimization, upgrades, replacements, and equipment modifications.
• Serve as a technical resource for equipment, processes, and systems during troubleshooting and cross-functional discussions.
• Monitor manufacturing processes and equipment performance, identify operational issues, and recommend solutions.
• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams on process and system improvements.
• Support deviations, equipment qualification, process validation, procedures, training, and New Product Introduction activities.
• Analyze operational data and present findings and recommendations for engineering projects and manufacturing issues.
• Apply engineering principles to system modifications, experiments, equipment improvements, and capital projects.
• Support design and construction projects, including reviewing technical documents, equipment quotes, project schedules, and cost estimates.
• Evaluate and resolve technical problems using analytical and troubleshooting skills while working under general supervision.
• Ensure manufacturing activities comply with corporate policies, industry standards, GMP/GLP requirements, and applicable regulatory expectations.
• Provide engineering support for 24/12 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.

Kenntnisse

Statistical analyses

Troubleshooting

Purification processes

GLP/GMP knowledge

Lab equipment operation

Regulatory documentation

Ausbildung

Bachelor’s degree in Engineering (Chemical Engineering preferred)

Jobbeschreibung

Quality Consulting Group, LLC seeks a talented engineer to support daily manufacturing operations in a regulated biotech/pharma environment in Puerto Rico and the US. You will troubleshoot processes, optimize operations, and participate in deviations, qualifications, and capital projects.

The role requires a Bachelor’s in Engineering (Chemical preferred), strong data analysis, and experience with GMP/GLP documentation. Flexibility for non-standard hours may be needed.