Purification Process Engineer (Biotech) – 24/7 Operations

Socket.dev; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a skilled engineer to provide technical support for daily manufacturing operations in Puerto Rico and the USA. The role involves troubleshooting, process optimization, and equipment modifications to sustain high-quality biotech production.

The candidate will collaborate with multi-disciplinary teams and ensure compliance with GMP/cGMP, quality systems, and regulatory expectations while supporting deviations, validations, and new product introductions.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field) required.
• Experience in biotechnology processes, specifically in purification operations.
• Knowledge of chromatography and UF/DF techniques.
• Understanding of purification equipment, processes, and operational best practices within a biotechnology manufacturing environment.
• Ability to follow GMP/cGMP procedures and documentation requirements in purification operations.
• Strong troubleshooting and problem-solving skills related to purification processes.
• Administrative Shift.

Responsibilities

• 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 24/7 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.

Skills

Troubleshooting

Problem-solving

Administrative Shift

Education

Bachelor’s degree in Engineering

Tools

Chromatography

UF/DF

Purification equipment

Job description

Quality Consulting Group, LLC is seeking a skilled engineer to provide technical support for daily manufacturing operations in Puerto Rico and the USA. The role involves troubleshooting, process optimization, and equipment modifications to sustain high-quality biotech production.

The candidate will collaborate with multi-disciplinary teams and ensure compliance with GMP/cGMP, quality systems, and regulatory expectations while supporting deviations, validations, and new product introductions.