Specialist Manufacturing - 35326

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 is responsible for supporting and optimizing manufacturing operations in a regulated environment. This role involves troubleshooting process issues, ensuring compliance with quality standards, and driving continuous improvement initiatives. The Specialist will collaborate cross-functionally with Manufacturing, Quality, and Process Development teams to ensure efficient and compliant production processes.

Key Responsibilities

• Support daily manufacturing operations to ensure compliance with established procedures, regulations, and production targets.
• Lead and/or support root cause investigations using tools such as Fishbone, 5 Whys, Six Boxes, and Kepner-Tregoe methodologies.
• Drive continuous improvement initiatives using Lean Manufacturing principles.
• Ensure adherence to Good Documentation Practices (GDP) in a regulated environment.
• Collaborate with cross-functional teams including Manufacturing, Quality, and Process Development to resolve technical issues.
• Generate and review technical documentation, reports, and presentations.
• Utilize manufacturing and quality systems such as TrackWise, VEEVA, MES, SmartSheet, and others to support operations.
• Support regulatory inspections, audits, and compliance activities as needed.
• Be available for extended work hours when required to support manufacturing demands.

Qualifications

• Doctorate degreeOR
• Master’s degree + 2 years of Manufacturing Operations experienceOR
• Bachelor’s degree + 4 years of Manufacturing Operations experience
  • Preferred: Educational background in Life Sciences, Biology, Chemistry, and/or Engineering

• Experience in bioprocessing unit operations
• Knowledge of Lean Manufacturing practices
• Familiarity with process monitoring platforms and data analytics tools

• Knowledge of root cause analysis tools (Fishbone, 5 Whys, Kepner-Tregoe, Six Boxes)
• Proficiency in systems and tools such as:
  • TrackWise
  • VEEVA
  • MES
  • SmartSheet
  • Power BI / Spotfire
  • CDOCS
  • Process monitoring platforms
  • AI tools (ChatGPT, Copilot)
• Strong technical writing and presentation 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.