Specialist Manufacturing - 35321

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.

Position Summary
The Specialist Manufacturing supports day-to-day manufacturing activities to ensure safe, compliant, and efficient operations in accordance with established procedures, quality standards, and business requirements. This role is responsible for supporting manufacturing processes, authoring and maintaining operational documentation, and managing documents within the document management system to ensure compliance with internal procedures and regulatory expectations. The Specialist collaborates closely with cross‑functional teams to ensure manufacturing documentation accuracy, workflow execution, and operational readiness.

Key Responsibilities

• Support manufacturing operations to ensure activities are executed in compliance with approved procedures, safety requirements, and business objectives.
• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Manage documentation workflows within the document management system, including routing, approvals, version control, and archiving.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Ensure manufacturing documents are current, accurate, and readily available to support operations.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to support documentation updates and continuous improvement initiatives.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Support investigations, corrective actions, and process improvements related to manufacturing documentation and operational activities, as needed.
• Ensure adherence to good documentation practices and company policies.
• Support overtime and extended coverage based on business needs.

Education & Experience Requirements
One of the following combinations is required:

• Doctorate degree OR
• Master’s degree and 3 years of Manufacturing Operations experience OR
• Bachelor’s degree and 5 years of Manufacturing Operations experience

Required Skills & Experience

• Proven experience working in a manufacturing environment.
• Experience authoring procedures and operational documentation.
• Experience managing documents within a document management system, including document workflows.
• Strong attention to detail and organizational skills.
• Strong written and verbal communication skills.

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.