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 Overview The Principal Project Scientist to support the Process Engineering organization as a backfill during the Pumitamig Technology Transfer. This role will provide scientific, technical, and compliance expertise to support Sterile Manufacturing Operations, serving as the primary subject matter expert (SME) and process owner for liquid and lyophilized parenteral products. The incumbent will ensure manufacturing processes remain in a validated state and compliant with cGMPs, site procedures, and regulatory requirements, while providing daily operational support and leadership across sterile operations.
Principal Objective Provide operational, scientific, and compliance expertise to support sterile manufacturing processes, including daily technical support, troubleshooting, investigations, CAPAs, validation documentation, and technology transfer activities. Serve as the end‑to‑end process owner for liquid and lyophilized parenteral manufacturing processes, ensuring robust, compliant, and efficient operations.
Responsibilities
Serve as Subject Matter Expert (SME) for liquid, lyophilized, and syringe parenteral processes and formulations, maintaining current knowledge of industry best practices.
Support Technology Transfer projects, including project planning, team formation, and execution for new product introductions.
Develop and execute experimental, characterization, and process validation protocols for sterile and non‑sterile processes.
Partner with Engineering, Automation, Information Management, Maintenance, and Manufacturing to ensure systems and equipment are capable of supporting transferred processes.
Lead or support manufacturing investigations (QEs), deviations, CAPAs, and procedure development and revisions.
Perform Design of Experiments (DOE) and Process Risk Assessments (FMEA) to define process control strategies and equipment characterization.
Ensure effective integration of resources and plans to meet timelines for process support, technology transfer, and validation activities.
Act as the communication liaison for transfer, validation, optimization, and routine process support for the assigned product portfolio.
Serve as a core team member on new product introduction and technology transfer teams.
Ensure compliance with cGMPs, EHS requirements, security guidelines, site procedures, and regulatory filings.
Required Qualifications
Bachelor’s degree in Engineering, Science, or related discipline.
Experience in sterile pharmaceutical manufacturing, including liquid and lyophilized parenteral processes.
Strong background in technology transfer, process validation, and manufacturing support.
Demonstrated experience leading investigations, CAPAs, and cross‑functional technical activities.
Strong knowledge of cGMPs, regulatory requirements, and pharmaceutical manufacturing operations.
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.
