Specialist Manufacturing - 35596

Mirus Consulting Group; Juncos (PR); On-site; USD 85,000 - 105,000; Full time

Job summary

mîrus Consulting Group in Humacao, Puerto Rico, is seeking a Specialist Manufacturing to provide technical support in a regulated environment. The role leads change controls, supports deviation investigations, drives process improvements, and collaborates across functions to ensure manufacturing readiness and compliance.

You will analyze data, manage documentation, and assist with training, CAPA assessments, and master batch record activities.

Qualifications

• Must have higher degree in Life Sciences or Engineering and manufacturing operations experience.
• Experience with bioprocessing unit operations and regulatory documentation practices.
• GDP in regulated environments and cross-functional collaboration are essential.

Responsibilities

• Own change controls for manufacturing process changes.
• Lead deviation investigations and CAPA including root cause analysis.
• Support risk assessments and microbial assessment evaluations.
• Coordinate campaign readiness and cross-functional communication.
• Develop and maintain training materials and assist on-the-floor troubleshooting.
• Create and revise Master Batch Records and related documentation.
• Assess process performance and implement improvement opportunities.

Skills

Communication skills

Technical writing

Presentation skills

Bilingual English/Spanish

Education

Doctorate degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

Bachelor’s degree in Life Sciences or Engineering

Tools

TrackWise

Spotfire

CDOCS

Process Monitoring Platforms

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 providing technical support to commercial manufacturing operations within a regulated environment. This role leads process-related change controls, supports deviation investigations, drives process improvements, and collaborates cross-functionally to ensure manufacturing readiness, operational efficiency, compliance, and continuous improvement. The incumbent serves as a recognized technical resource, supporting manufacturing processes through data analysis, risk assessments, troubleshooting, documentation management, and implementation of process changes throughout the product lifecycle.

Key Responsibilities

• Own change controls for manufacturing process changes
• Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• Support Risk Assessments exercises and Microbial assessment evaluations.
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Complete assessments for CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.

Minimum Qualifications

• Doctorate Degree; OR
• Master’s Degree and 2 years of Manufacturing Operations experience; OR
• Bachelor’s Degree and 4 years of Manufacturing Operations experience
  • Preferred educational background in Life Sciences and/or Engineering.

Preferred Qualifications

• In-depth experience with bioprocessing unit operations, including Cell Culture and Drug Substance Purification.
• Knowledge of Root Cause Analysis methodologies, including:
  • Fishbone Diagram
  • Six Boxes
  • 5 Whys
  • Kepner-Tregoe
• Familiarity with Lean Manufacturing principles and practices.
• Ability to effectively communicate and collaborate with technical and management personnel within Manufacturing, Process Development, and Quality organizations.
• Proficiency in Good Documentation Practices (GDP) within a regulated environment.
• Experience with:
  • TrackWise
  • Spotfire
  • CDOCS
  • Process Monitoring Platforms
• Strong technical writing and presentation skills.
• Excellent verbal and written communication skills in English and Spanish.

Schedule

Monday-Friday | 8:00 AM - 5:00 PM

Work Arrangement

Flexibility for on-call support as business needs require.

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.