Engineer - 35844

Mirus Consulting Group; Juncos (PR); On-site; USD 75,000 - 100,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, seeks an Engineer to provide technical support for manufacturing operations in a regulated biotechnology environment. The role focuses on process optimization, data analysis, and cross-functional collaboration to ensure compliant and reliable drug substance manufacturing.

Candidates should have advanced engineering credentials and experience in biotechnology or pharma, with strong analytical and problem-solving skills and a commitment to GMP and

Qualifications

• Master’s degree in Engineering or a Bachelor's with 2+ years of engineering experience.
• Preferred background: Chemical Engineering.

Responsibilities

• Function as a technical expert to equipment or systems regarding troubleshooting operations.
• Evaluate, select and apply standard engineering techniques and procedures under general supervision.
• Work with project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Collaborate with manufacturing, process development, quality assurance and validation to develop requirements for system modifications.
• Perform statistical analysis and data evaluation to support engineering and manufacturing decisions.
• Support process monitoring, troubleshooting, investigations and CAPA implementation.

Skills

Statistical analysis

Cross-functional collaboration

GMP knowledge

Problem-solving

Education

Master’s degree in Engineering

Bachelor’s degree in Engineering with 2 years experience

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Job Summary

We are seeking a motivated Engineer to provide technical support for manufacturing operations within a regulated biotechnology environment. The successful candidate will support process optimization initiatives, analyze operational data, investigate process performance issues, and collaborate with cross-functional teams to ensure reliable and compliant manufacturing processes. This role offers an excellent opportunity for engineers with strong analytical and problem-solving skills who are interested in supporting drug substance manufacturing operations.

Key Responsibilities

• Function as a technical expert to equipment or systems regarding troubleshooting operations.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
• Experience performing statistical analysis and data evaluation to support engineering and manufacturing decisions.
• Analyze manufacturing data using statistical tools and methodologies to identify trends, variability, and opportunities for process improvement.
• Experience within the biotechnology, pharmaceutical, or life sciences industry.
• Knowledge of drug substance manufacturing processes and/or technical support activities.
• Support process monitoring, troubleshooting, investigations, and implementation of corrective and preventive actions (CAPAs).
• Collaborate with Manufacturing, Process Development, Quality, Validation, and other cross-functional teams to resolve technical issues.
• Assist in the evaluation and implementation of process improvements aimed at increasing operational performance and product quality.
• Ensure compliance with GMP, safety, environmental, and company requirements.

Minimum Qualifications

• Master’s degree in Engineering, OR
• Bachelor’s degree in Engineering with a minimum of 2 years of engineering experience.
  • Preferred background: Chemical Engineering

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.