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.