Specialist Manufacturing - 35601

Mirus Consulting Group; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico is seeking a Specialist Manufacturing to provide technical and operational support in a regulated environment. The role focuses on safe, efficient production and ongoing improvement across cross-functional teams.

Responsibilities include troubleshooting, CAPA execution, process validation, equipment qualification, and documentation. Candidates should have advanced engineering credentials with experience in regulated manufacturing settings.

Qualifications

• Doctorate, or Master's with 2 years of Manufacturing Operations experience.
• Bachelor's with 4 years of Manufacturing Operations experience.
• Preferred background in Chemical, Mechanical, Industrial Engineering or Biotechnology.

Responsibilities

• Provide technical support to manufacturing operations to ensure safe, efficient, and compliant production activities.
• Evaluate processes for optimization, productivity gains, and waste reduction.
• Troubleshoot process issues and drive CAPA activities.
• Support investigations related to deviations, non-conformances, and excursions.
• Collaborate with cross-functional teams to resolve manufacturing challenges.
• Monitor performance indicators and recommend improvements.
• Support process validation, equipment qualification, tech transfer, and startup activities.
• Ensure compliance with cGMP and regulatory requirements.
• Participate in continuous improvement initiatives using Lean Six Sigma, Kaizen, and RCA.
• Prepare, review, and update manufacturing documentation.

Skills

Communication skills

Cross-functional teamwork

Problem solving

Education

Doctorate degree

Master's degree

Bachelor's degree

Tools

Lean Six Sigma

Kaizen

Root Cause Analysis

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.

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

• 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.