Specialist Manufacturing - 35716

Mirus Consulting Group; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Manufacturing to support regulated manufacturing operations by developing, reviewing, and managing manufacturing documentation to ensure compliance with quality and regulatory requirements.

The role partners with operators and cross-functional teams to implement documentation updates, drive process standardization, and assist during audits.

Qualifications

• Experience in Manufacturing Operations within a regulated manufacturing environment.
• Experience in Document Management, including document creation, revision, review, and approval processes.
• Strong understanding of manufacturing procedures, work instructions, and controlled documentation systems.
• Ability to work closely with manufacturing operators and cross-functional teams.
• Strong organizational, communication, and technical writing skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office applications and electronic document management systems.

Responsibilities

• Create, revise, review, and coordinate the approval of manufacturing documents, including SOPs, Batch Records, Work Instructions, Forms, and related documentation.
• Ensure manufacturing documentation is accurate, compliant, and aligned with current operational practices.
• Collaborate directly with manufacturing operators to gather process information and support document development and updates.
• Support document lifecycle management activities, including creation, revision control, routing, approval, implementation, and archival.
• Partner with Manufacturing, Engineering, Quality, and other functional areas to ensure documentation changes are properly evaluated and implemented.
• Review manufacturing processes and identify opportunities for process standardization and documentation improvements.
• Provide support during audits, inspections, and regulatory assessments by ensuring documents are current and readily available.
• Maintain compliance with company policies, procedures, safety requirements, and applicable regulatory expectations.
• Support operational excellence initiatives and contribute to improving manufacturing performance.

Skills

Manufacturing Operations

Document Management

Technical Writing

Cross-functional Collaboration

MS Office

EDMS

Education

Doctorate Degree

Master's Degree + 2 years Manufacturing Operations experience

Bachelor's Degree + 4 years Manufacturing Operations experience

Job description

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 developing, reviewing, revising, and managing manufacturing documentation to ensure compliance with operational, quality, and regulatory requirements. This role works closely with manufacturing operators and cross-functional teams to support efficient production processes, implement documentation updates, and drive continuous improvement initiatives within the manufacturing environment. The successful candidate must be flexible and available to support different shifts based on business and operational needs.

Key Responsibilities

• Create, revise, review, and coordinate the approval of manufacturing documents, including Standard Operating Procedures (SOPs), Batch Records, Work Instructions, Forms, and related documentation.
• Ensure manufacturing documentation is accurate, compliant, and aligned with current operational practices.
• Collaborate directly with manufacturing operators to gather process information and support document development and updates.
• Support document lifecycle management activities, including document creation, revision control, routing, approval, implementation, and archival.
• Partner with Manufacturing, Engineering, Quality, and other functional areas to ensure documentation changes are properly evaluated and implemented.
• Review manufacturing processes and identify opportunities for process standardization and documentation improvements.
• Provide support during audits, inspections, and regulatory assessments by ensuring manufacturing documentation is current and readily available.
• Maintain compliance with company policies, procedures, safety requirements, and applicable regulatory expectations.
• Support operational excellence initiatives and contribute to improving manufacturing performance.

Qualifications

One of the following combinations of education and experience is required:

• Doctorate Degree, OR
• Master's Degree and 2 years of Manufacturing Operations experience, OR
• Bachelor's Degree and 4 years of Manufacturing Operations experience

Required Qualifications

• Experience in Manufacturing Operations within a regulated manufacturing environment.
• Experience in Document Management, including document creation, revision, review, and approval processes.
• Strong understanding of manufacturing procedures, work instructions, and controlled documentation systems.
• Ability to work closely with manufacturing operators and cross-functional teams.
• Strong organizational, communication, and technical writing skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office applications and electronic document management systems.

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.