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Specialist Manufacturing - 35686
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 manufacturing operations by leading and coordinating documentation activities, change controls, process improvements, and cross-functional projects within a regulated environment. This role ensures compliance with quality and operational requirements while driving efficiency and supporting manufacturing objectives.
Key Responsibilities
Candidates must meet one of the following education and experience combinations:
Position Summary
The Specialist Manufacturing is responsible for supporting manufacturing operations by leading and coordinating documentation activities, change controls, process improvements, and cross-functional projects within a regulated environment. This role ensures compliance with quality and operational requirements while driving efficiency and supporting manufacturing objectives.
Key Responsibilities
- Support daily manufacturing operations to ensure compliance with established procedures, GMP requirements, and company standards.
- Author, review, revise, and maintain manufacturing documentation, including procedures, work instructions, reports, and technical documents.
- Manage document lifecycle activities through Veeva Vault (CDOCs) or similar document management systems.
- Own Change Control, ensuring timely completion and implementation of required actions.
- Lead and support manufacturing-related projects, including project planning, tracking, execution, and closure.
- Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, Validation, Regulatory, and Supply Chain.
- Track project deliverables, timelines, and action items using Smartsheet or similar project management platforms.
- Identify opportunities for process improvements and support implementation initiatives.
- Ensure documentation and project activities are completed in accordance with regulatory requirements and internal quality systems.
- Support at investigations, deviations, CAPAs, and continuous improvement efforts as required.
Candidates must meet one of the following education and experience combinations:
- Doctorate Degree OR
- Master’s Degree and 2 years of Manufacturing Operations experience OR
- Bachelor’s Degree and 4 years of Manufacturing Operations experience
- Experience with Veeva Vault (CDOCs) or similar document management platforms.
- Strong technical writing skills and experience authoring GMP documentation.
- Experience owning and managing Change Controls.
- Demonstrated project management and project coordination experience.
- Proficiency with Smartsheet or similar project tracking and management tools.
- Strong organizational and time management skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Excellent verbal and written communication skills.
- Experience working in a regulated pharmaceutical, biotechnology, or medical device environment preferred.