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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 within a regulated biopharmaceutical environment. This role provides technical expertise to ensure safe, compliant, and efficient manufacturing processes while driving continuous improvement initiatives. The incumbent will collaborate cross-functionally with Manufacturing, Quality, Process Development, Engineering, and Management teams to resolve process issues, improve operational performance, and maintain compliance with applicable regulatory requirements.
Key Responsibilities
Knowledge and experience with the following systems and tools: TrackWise, Veeva, Manufacturing Execution Systems (MES), SmartSheet, Microsoft Copilot, ChatGPT, Power BI, Spotfire, CDOCS and Process Monitoring Platforms
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.
Position Summary
The Specialist Manufacturing is responsible for supporting and optimizing manufacturing operations within a regulated biopharmaceutical environment. This role provides technical expertise to ensure safe, compliant, and efficient manufacturing processes while driving continuous improvement initiatives. The incumbent will collaborate cross-functionally with Manufacturing, Quality, Process Development, Engineering, and Management teams to resolve process issues, improve operational performance, and maintain compliance with applicable regulatory requirements.
Key Responsibilities
- Support daily manufacturing operations to ensure production objectives, quality standards, and compliance requirements are achieved.
- Provide technical troubleshooting and process support for bioprocessing unit operations.
- Lead and participate in investigations related to manufacturing deviations, non-conformances, and process events.
- Serve as the Deviation Owner for manufacturing-related events, ensuring timely initiation, investigation, resolution, and closure of deviations in accordance with site procedures and regulatory requirements.
- Lead and manage major and critical deviation investigations, ensuring thorough fact-finding, impact assessment, and documentation
- Apply root cause analysis methodologies, including 5 Whys, Fishbone Diagram, Kepner-Tregoe, Six Boxes, and other structured problem-solving tools.
- Drive continuous improvement initiatives utilizing Lean Manufacturing principles and best practices.
- Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and site procedures.
- Author, review, and revise technical documents, including investigations, reports, procedures, protocols, and presentations.
- Utilize manufacturing and quality systems to monitor, document, and manage operational activities.
- Collaborate effectively with cross-functional teams including Manufacturing, Quality, Process Development, Engineering, and site leadership.
- Work independently with minimal supervision while effectively managing multiple priorities in a fast-paced environment.
- Support extended work hours and overtime when required to meet business objectives.
- Doctorate Degree with relevant manufacturing experience; OR
- Master’s Degree and 2 years of Manufacturing Operations experience; OR
- Bachelor’s Degree and 4 years of Manufacturing Operations experience
- Experience supporting biopharmaceutical or biotechnology manufacturing operations.
- Hands-on knowledge of bio-processing unit operations.
- Experience working in highly regulated GMP environments.
- Familiarity with Lean Manufacturing tools and continuous improvement methodologies.
- Strong technical writing, reporting, and presentation skills.
Knowledge and experience with the following systems and tools: TrackWise, Veeva, Manufacturing Execution Systems (MES), SmartSheet, Microsoft Copilot, ChatGPT, Power BI, Spotfire, CDOCS and Process Monitoring Platforms
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.