Tttle: Manufacturing Specialist

Location: Juncos, PR

Duration: 5 Months

Manufacturing Specialist

Position Summary

The Manufacturing Specialist supports manufacturing and quality operations within a regulated environment with minimal supervision. This role is responsible for executing and improving key manufacturing and quality systems, including non-conformance management, process validation, procedural documentation, training programs, and new product introductions (NPI).

The ideal candidate will leverage technical, operational, and scientific expertise, along with strong analytical and troubleshooting skills, to support manufacturing processes, ensure compliance, and drive continuous improvement initiatives. This position may serve as a primary process owner for designated manufacturing systems and provide support for more complex process ownership responsibilities.

Key Responsibilities

Applied Process Expertise

• Initiate, revise, review, and approve manufacturing procedures to ensure compliance with current operational and regulatory requirements.
• Serve as the document owner for assigned manufacturing procedures and controlled documentation.
• Evaluate process performance through floor observations, data analysis, and performance monitoring.
• Identify, assess, and implement process improvement opportunities to enhance efficiency, quality, and compliance.
• Provide technical troubleshooting support for manufacturing processes and equipment.
• Develop and maintain training materials and assist in delivering technical and scientific training to manufacturing personnel.

Process Monitoring

• Support the establishment and maintenance of process monitoring parameters and control limits.
• Collect, analyze, and interpret process monitoring data to identify trends and assess process performance.
• Support deviation investigations and recommend corrective actions as needed.
• Prepare and contribute to quarterly process monitoring reports in a timely manner.

Non-Conformance (NC) and CAPA Management

• Ensure non-conformances are properly triaged and addressed within established timelines.
• Author investigation reports and supporting documentation.
• Execute corrective and preventive actions (CAPA) to address quality and process-related issues.
• Manage NC/CAPA activities through closure while meeting established quality objectives.
• Monitor, analyze, and communicate incident trends to key stakeholders.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.

Process Validation

• Assist in the development of process validation protocols and final reports.
• Support execution of process validation activities in accordance with approved procedures.
• Collect, analyze, and interpret validation data to ensure process performance and compliance requirements are met.

Regulatory Compliance and New Product Introductions

• Participate in regulatory inspections, audits, and compliance readiness activities.
• Support New Product Introduction (NPI) projects by evaluating documentation, training, materials, and equipment requirements.
• Assess, prioritize, justify, and support implementation of process and equipment modification projects.
• Provide project coordination and implementation support for manufacturing improvements and operational initiatives.

Change Control

• Support Manufacturing Change Owners with Change Control Review Board (CCRB) packages affecting manufacturing processes.
• Assist in evaluating and implementing approved process changes.

Projects and Continuous Improvement

• Participate in special projects and strategic initiatives designed to improve operational performance, compliance, and manufacturing efficiency.
• Support continuous improvement efforts through process optimization and best practices.
• Perform additional duties and responsibilities as assigned.

Preferred Qualifications

• Educational background in Life Sciences, Biology, Chemistry, Engineering, Biotechnology, or a related scientific discipline.
• Experience supporting manufacturing operations in biotechnology, pharmaceutical, medical device, or other regulated industries.
• Strong understanding of bioprocessing unit operations and manufacturing processes.
• Knowledge of Lean Manufacturing principles and continuous improvement methodologies.
• Experience conducting Root Cause Analysis (RCA) using methodologies such as:
• Fishbone (Ishikawa) Diagrams
• 5 Whys
• Kepner-Tregoe
• Six Boxes Methodology
• Proficiency in Good Documentation Practices (GDP) within a regulated manufacturing environment.
• Experience working with manufacturing and quality systems, including:
• TrackWise
• Veeva
• Manufacturing Execution Systems (MES)
• Smartsheet
• Power BI
• Spotfire
• CDOCS
• Process Monitoring Platforms
• Microsoft Copilot
• ChatGPT
• Strong technical writing, presentation, and documentation skills.
• Excellent verbal and written communication skills in both English and Spanish.
• Strong interpersonal and relationship-building skills.
• Ability to work effectively in cross-functional teams.
• Self-motivated and capable of working independently with minimal supervision.
• Ability to manage multiple priorities in a fast-paced, high-pressure environment.
• Flexibility to work extended hours when business needs require.

Education and Experience Requirements

Candidates must meet one of the following combinations of education and experience:

• Doctorate Degree
• OR
• Master's Degree with a minimum of 2 years of Manufacturing Operations experience
• OR
• Bachelor's Degree with a minimum of 4 years of Manufacturing Operations experience
• OR
• Associate Degree with a minimum of 8 years of Manufacturing Operations experience
• OR
• High School Diploma/GED with a minimum of 10 years of Manufacturing Operations experience

Required Competencies and Skills

• Strong technical understanding of bioprocessing unit operations.
• Experience performing GMP manufacturing and production operations.
• Knowledge of regulatory compliance requirements and agency interactions.
• Ability to contribute to and lead cross-functional teams.
• Strong collaboration skills with Manufacturing, Process Development, Engineering, Validation, and Quality organizations.
• Excellent organizational, technical writing, and presentation skills.
• Basic project management and project coordination capabilities.
• Knowledge of statistical process control and control charting methodologies.
• Strong analytical thinking and problem-solving skills.
• Effective troubleshooting and decision-making abilities.
• Commitment to safety, quality, compliance, and operational excellence.