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.
Position Summary The Senior Engineer is responsible for providing advanced engineering support to manufacturing operations in a regulated environment. This role focuses on process optimization, troubleshooting, and implementation of continuous improvement initiatives to ensure efficient, compliant, and reliable production processes. The Senior Engineer partners cross-functionally with Operations, Quality, and Maintenance teams to drive operational excellence and technical solutions.
Key Responsibilities
Provide engineering support to manufacturing operations, ensuring process reliability, efficiency, and compliance with regulatory requirements.
Lead and support troubleshooting and root cause investigations for process and equipment issues.
Develop and implement corrective and preventive actions (CAPA).
Drive continuous improvement initiatives using methodologies such as Lean Six Sigma, Kaizen, and root cause analysis.
Support process optimization and technology improvements to enhance performance and reduce variability.
Collaborate with cross-functional teams (Operations, Quality, Maintenance) to ensure alignment and successful execution of initiatives.
Ensure adherence to cGMP standards, regulatory requirements, and documentation practices.
Participate in risk assessments, change control processes, and validation activities as required.
Support audits, inspections, and regulatory interactions.
Maintain technical documentation and generate reports to communicate findings and recommendations.
Qualifications
Doctorate degree OR
Master’s degree + 2 years of Engineering experience OR
Bachelor’s degree in Engineering + 4 years of Engineering experience
Academic background in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology
Experience in manufacturing operations within regulated industries such as biotech, pharmaceutical, or similar
Hands-on experience in process engineering, production support, or manufacturing systems
Knowledge of automation systems and process equipment
Experience with continuous improvement methodologies (Lean Six Sigma, Kaizen)
Strong root cause analysis and problem-solving skills
Experience implementing CAPA and process optimization strategies
Understanding of cGMP regulations, compliance, and documentation practices
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.