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
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Position Summary
The
Specialist Manufacturing provides technical and operational support to manufacturing operations within a regulated environment. This role is responsible for ensuring safe, efficient, and compliant manufacturing processes while supporting continuous improvement initiatives, troubleshooting operational challenges, and partnering with cross-functional teams to drive business results. The incumbent serves as a key technical resource to optimize manufacturing performance, maintain compliance, and support operational excellence objectives.
Key Responsibilities
- Provide technical support to manufacturing operations to ensure safe, efficient, and compliant production activities.
- Evaluate manufacturing processes and identify opportunities for optimization, productivity improvements, and waste reduction.
- Troubleshoot manufacturing process issues and implement effective corrective and preventive actions (CAPA).
- Support investigations related to deviations, non-conformances, and process excursions.
- Collaborate with Operations, Quality, Engineering, Maintenance, and other functional groups to resolve manufacturing challenges.
- Monitor manufacturing performance indicators and recommend process improvements.
- Support process validation, equipment qualification, technology transfer, and startup activities as required.
- Ensure compliance with cGMP regulations, company procedures, and applicable regulatory requirements.
- Participate in continuous improvement initiatives utilizing Lean Six Sigma, Kaizen, Root Cause Analysis, and other operational excellence tools.
- Prepare, review, and update manufacturing documentation, including SOPs, batch records, protocols, reports, and change controls.
- Support implementation of process enhancements and operational best practices.
- Promote a culture of safety, quality, compliance, and continuous improvement.
Qualifications
Candidates must possess one of the following qualifications:
- Doctorate degree, OR
- Master's degree and 2 years of Manufacturing Operations experience, OR
- Bachelor's degree and 4 years of Manufacturing Operations experience
- Preferred academic background in Engineering disciplines, including: Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biotechnology.
Preferred Qualifications
- Experience supporting Manufacturing Operations within biotechnology, pharmaceutical, medical device, or other regulated environments.
- Hands-on engineering experience in process engineering, manufacturing support, or production systems.
- Technical knowledge of manufacturing process equipment, automation systems, and production technologies.
- Experience applying Lean Six Sigma, Kaizen, Root Cause Analysis, and other continuous improvement methodologies.
- Demonstrated ability to troubleshoot manufacturing issues and drive process optimization initiatives.
- Experience with investigations, CAPA development, and implementation.
- Strong understanding of cGMP requirements, compliance standards, and manufacturing documentation practices.
- Proven ability to work effectively in cross-functional teams and fast-paced manufacturing environments.
- Excellent verbal and written communication skills.
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.
