mirus 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 SummaryThe 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.