View all jobs
Specialist Manufacturing - 35632
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 providing technical and operational support to manufacturing processes within a regulated pharmaceutical/biotechnology environment. This role ensures manufacturing documentation, procedures, and processes remain compliant with cGMP requirements while driving continuous improvement initiatives, changing management activities, process validation support, and operational excellence. The Manufacturing Specialist collaborates cross-functionally to maintain product quality, process efficiency, and regulatory compliance.
Key Responsibilities
Position Summary
The Specialist Manufacturing is responsible for providing technical and operational support to manufacturing processes within a regulated pharmaceutical/biotechnology environment. This role ensures manufacturing documentation, procedures, and processes remain compliant with cGMP requirements while driving continuous improvement initiatives, changing management activities, process validation support, and operational excellence. The Manufacturing Specialist collaborates cross-functionally to maintain product quality, process efficiency, and regulatory compliance.
Key Responsibilities
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
- Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Ensures that processes and procedures are aligned with cGMP requirements and/or other applicable regulations
- Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and efficiency of the product(s) manufactured
- Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training.
- Assist with generation and the implementation of process validation protocols and reports.
- Participate in regulatory inspections
- Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
- Assess, prioritize, support, and provide implementation and project management support for process or equipment modification projects.
- Own Change Control and ensure implementation within the established goal.
- Assist manufacturing change owner on CCRB packages impacting the process.
- Participate in noncommercial activity runs to support the collection and analysis of process data.
- Participate in the assessment or implementation of special projects or initiatives.
- 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 in biotechnology, pharmaceutical, medical devices, or other highly regulated manufacturing environments.
- Knowledge of cGMP, FDA regulations, and validation principles.
- Experience with Electronic Batch Records (EBR) systems.
- Experience managing Change Controls and supporting deviation investigations.
- Strong project management and continuous improvement skills.
- Ability to analyze manufacturing data and make data-driven decisions.
- Excellent communication, technical writing, and cross-functional collaboration skills.
- Administrative Shift: Monday through Friday, 8:00 AM to 5:00 PM
- Overtime: May be required based on business needs.