JT844 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

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 24/12 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.

Skills

Statistical analyses

Troubleshooting

Purification processes

GLP/GMP knowledge

Lab equipment operation

Regulatory documentation

Education

Bachelor’s degree in Engineering (Chemical Engineering preferred)

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 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 24/12 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.

Qualifications

• Bachelor’s degree in Engineering (Chemical Engineering Preferred)
• Statistical Analyses experience
• 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
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Strong troubleshooting and problem-solving skills related to purification processes.
• 1st and 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.