JT778 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a motivated engineer to provide technical support for daily manufacturing operations in Puerto Rico and the USA. You will troubleshoot processes, optimize operations, and collaborate with cross-functional teams to improve equipment performance and product quality.

The role requires a Bachelor's degree in Engineering with biotech purification experience, knowledge of chromatography and UF/DF, and a strong focus on GMP/cGMP practices.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field).
• 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

Chromatography

UF/DF

Purification processes

Biotech manufacturing

Education

Bachelor’s degree in Engineering

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

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.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field).
• Experience in biotechnology processes, specifically in purification operations.
• Knowledge of chromatography and Ultrafiltration/Diafiltration (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

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.