Pharma Manufacturing Engineer - 24/7 Operations

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

7/24 shift availability

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join the team in Puerto Rico/USA, providing technical support for daily pharmaceutical and biotech manufacturing operations. The role includes troubleshooting, process optimization, equipment modifications, and cross-functional collaboration.

The ideal candidate holds a Bachelor’s degree in Engineering and has experience with GMP/GLP environments, equipment qualification, and process validation.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field) required.
• Able to support non-standard shift manufacturing operations including nights and weekends.
• Experience or working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Familiarity with GMP/GLP and highly regulated manufacturing environments.
• Knowledge of equipment qualification and process validation.
• Experience with validation protocol execution or protocol writing.
• Ability to apply engineering principles and scientific knowledge to manufacturing operations.
• Strong troubleshooting, analytical problem-solving, and technical decision-making skills.
• Ability to prepare technical reports and presentations.
• Strong verbal and written communication skills.
• Experience supporting equipment, process, or system modifications.
• Computer proficiency and ability to work with specialized laboratory or manufacturing equipment.
• Ability to manage changing priorities and work effectively with cross-functional teams.
• Strong organizational skills and attention to detail.
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.

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

Analytical thinking

Technical writing

Communication

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join the team in Puerto Rico/USA, providing technical support for daily pharmaceutical and biotech manufacturing operations. The role includes troubleshooting, process optimization, equipment modifications, and cross-functional collaboration.

The ideal candidate holds a Bachelor’s degree in Engineering and has experience with GMP/GLP environments, equipment qualification, and process validation.