Specialist Manufacturing - 35451

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 Manufacturing Specialist (Deviation Owner) is responsible for supporting manufacturing operations within a regulated environment, ensuring process compliance, and leading deviation investigations. This role requires strong technical expertise, problem-solving skills, and the ability to collaborate cross-functionally with Manufacturing, Quality, and Process Development teams to maintain operational excellence and regulatory compliance.

Key Responsibilities

• Serve as Deviation Owner, leading investigations, root cause analysis, and closure of manufacturing deviations.
• Perform and document root cause analysis using methodologies such as Fishbone (Ishikawa), 5 Whys, Six Boxes, and Kepner-Tregoe.
• Familiarity with systems/tools such as:
  • TrackWise
  • Veeva
  • MES
  • SmartSheet
  • Power BI / Spotfire
  • CDOCS
  • Process monitoring platforms
  • AI tools (ChatGPT, Copilot)
• Support manufacturing operations and bio-processing unit operations to ensure compliance with established procedures and quality standards.
• Collaborate with cross-functional teams including Manufacturing, Quality, and Process Development to implement corrective and preventive actions (CAPAs).
• Ensure adherence to Good Documentation Practices (GDP) in a highly regulated environment.
• Identify process improvements aligned with Lean Manufacturing principles.
• Generate, review, and present technical reports and documentation.
• Strong technical writing and presentation skills.
• Utilize systems and tools to support operations tracking, documentation, and analysis.
• Support audits, inspections, and internal compliance activities.
• Work under minimal supervision in a fast-paced, high-pressure environment.
• May be required to work extended hours to support operational needs.

Qualifications

• Doctorate degree, OR
• Master’s degree + 2 years of Manufacturing Operations experience, OR
• Bachelor’s degree + 4 years of Manufacturing Operations experience

Educational background in Life Sciences, Biology, Chemistry, or Engineering

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.