Specialist Manufacturing - 35561

Mirus Consulting Group; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Manufacturing to lead deviation investigations and drive timely resolutions. You will serve as the investigation owner, perform root cause analyses, and collaborate with Manufacturing, Engineering, Quality, Validation, and other groups to ensure compliance and continuous improvement.

Ideal candidates will have experience in biotech, pharmaceutical, or regulated manufacturing environments and a background in managing

Qualifications

• Doctorate or Master’s degree with Manufacturing Operations experience.
• Bachelor’s degree with 4 years of Manufacturing Operations experience, engineering is a plus.

Responsibilities

• Lead and manage manufacturing deviation investigations from initiation through closure.
• Serve as the investigation owner, ensuring timely completion of investigations and documentation.
• Conduct detailed root cause analyses to identify underlying causes of manufacturing events and deviations.
• Evaluate impact of deviations on processes, product quality, compliance, and operations.
• Utilize TrackWise or similar quality systems to document and track investigations.
• Partner with cross-functional teams to implement corrective actions and CAPAs where applicable.
• Support regulatory readiness and site procedures compliance.

Skills

Deviation management

Investigation ownership

Root cause analysis

Quality systems

CAPA

GxP knowledge

Cross-functional collaboration

Documentation

Analytical thinking

Education

Doctorate degree

Master's degree

Bachelor's degree

Engineering degree

Tools

TrackWise

Quality management systems

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 will support Manufacturing Operations by leading and managing deviation investigations, performing impact assessments, and driving the timely resolution of manufacturing-related events. The ideal candidate will have hands-on experience serving as an investigation owner, conducting thorough root cause analyses, and collaborating with cross-functional teams to ensure compliance, operational effectiveness, and continuous improvement. This position requires experience within Manufacturing environments, with a strong preference for candidates who have worked in the biotechnology, pharmaceutical, or regulated manufacturing industries. Candidates with experience managing customer complaints and associated investigations will also be considered.

Key Responsibilities

• Lead and manage manufacturing deviation investigations from initiation through closure.
• Serve as the investigation owner, ensuring timely completion of investigations and associated documentation.
• Conduct detailed root cause analyses to identify underlying causes of manufacturing events and process deviations.
• Evaluate the potential impact of deviations on manufacturing processes, product quality, compliance, and operations.
• Utilize TrackWise or similar quality systems to document, track, and manage investigations and deviation records.
• Partner with Manufacturing, Engineering, Quality, Validation, and other functional groups to gather information, evaluate findings, and implement corrective actions.
• Support the development and execution of corrective and preventive actions (CAPAs) when applicable.
• Ensure investigations are conducted in accordance with site procedures, GMP requirements, and regulatory expectations.
• Identify trends and recurring issues and recommend process improvements to reduce deviation recurrence.
• Support operational excellence and continuous improvement initiatives within Manufacturing Operations.
• Assist during audits, inspections, and regulatory assessments by providing investigation-related documentation and support.
• Prepare technical reports and investigation summaries for management review.

Minimum 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
• Bachelor's Degree in Engineering is a plus.

Required Qualifications and Experience

• Experience managing manufacturing deviations and investigation records.
• Demonstrated experience as an investigation owner, including leading investigations through closure.
• Strong experience performing root cause analysis in Manufacturing Operations environments.
• Experience conducting deviation assessments and impact evaluations.
• Working knowledge of TrackWise or similar quality management systems.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent organizational and documentation skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong written and verbal communication skills.
• Ability to work effectively in a cross-functional team environment.

Schedule: Administrative Shift (8 hours)

Overtime: Availability to work overtime may be required based on business demands.

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.