Tittle: Manufacturing Specialist (35380)

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)

Work Schedule: On-Site | Administrative Shift

Contract Duration: 5 Months

Position Summary

We are seeking a Manufacturing Specialist to support manufacturing and quality operations within a regulated production environment. Working with minimal supervision, the successful candidate will contribute to the execution and continuous improvement of manufacturing and quality systems, including non-conformances, process validation, procedures, training programs, and new product introductions (NPI).

This role requires the application of scientific, operational, and technical expertise to support manufacturing processes, ensure compliance, troubleshoot operational issues, and drive process improvements. The Manufacturing Specialist may serve as a primary process owner for designated systems and provide support for more complex manufacturing processes.

Preferred Qualifications

• Bachelor's degree or higher in Engineering, Biotechnology, Life Sciences, Chemistry, or a related technical discipline.
• Experience supporting manufacturing operations within biotechnology, pharmaceutical, medical device, or other regulated industries.
• Hands-on experience in process engineering, manufacturing support, or production systems.
• Familiarity with automation systems, manufacturing equipment, and continuous improvement methodologies such as Lean Six Sigma, Kaizen, and Root Cause Analysis.
• Proven ability to troubleshoot manufacturing issues and implement effective corrective and preventive actions (CAPA).
• Experience collaborating with cross-functional teams, including Operations, Quality, Engineering, and Maintenance.
• Working knowledge of cGMP regulations, compliance requirements, and documentation practices.
• Strong communication, organizational, and problem-solving skills.
• Ability to adapt and perform effectively in a fast-paced and dynamic environment.

Key Responsibilities

Applied Process Expertise

• Initiate, revise, review, and approve manufacturing procedures while ensuring documentation accurately reflects current operations.
• Serve as a document owner for assigned procedures and records.
• Monitor process performance through floor observations and data analysis.
• Identify, evaluate, and implement process improvement opportunities.
• Provide technical troubleshooting support for manufacturing operations.
• Assist in the development of training materials and support the delivery of technical and scientific training.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Assist in the assessment and investigation of process deviations.
• Support the timely preparation and execution of quarterly process monitoring reports.

Non-Conformance (NC) and CAPA Management

• Ensure all non-conformances are triaged within established timelines.
• Author investigation reports and related documentation.
• Execute corrective and preventive actions (CAPA).
• Manage NC/CAPA activities through closure within established performance goals.
• Monitor, analyze, and communicate incident trends.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.

Process Validation

• Assist in the development of process validation protocols and reports.
• Support execution of process validation activities.
• Collect, analyze, and interpret validation data to ensure process performance and compliance.

Regulatory Support

• Participate in regulatory inspections and audits as required.
• Support compliance initiatives and regulatory readiness activities.

New Product Introductions (NPI) and Process Modifications

• Participate in New Product Introduction activities to assess documentation, training, material, and equipment requirements.
• Evaluate, prioritize, justify, and support implementation of process and equipment modification projects.
• Provide project coordination and implementation support for manufacturing improvement initiatives.

Change Control

• Support Manufacturing Change Owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.

Projects and Continuous Improvement Initiatives

• Participate in special projects and strategic initiatives aimed at improving manufacturing performance, compliance, and operational excellence.
• Perform additional duties and responsibilities as assigned.

Education and Experience Requirements

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

• Doctorate Degree
• OR
• Master's Degree plus 2 years of Manufacturing Operations experience
• OR
• Bachelor's Degree plus 4 years of Manufacturing Operations experience
• OR
• Associate degree plus 8 years of Manufacturing Operations experience
• OR
• High School Diploma/GED plus 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 requirements and agency interactions.
• Ability to participate in and support cross-functional teams.
• Strong communication and collaboration skills with technical and management personnel across Manufacturing, Process Development, Engineering, and Quality organizations.
• Excellent organizational, technical writing, and presentation skills.
• Basic project management capabilities.
• Working knowledge of statistical process control and control charting techniques.
• Strong analytical and problem-solving abilities with attention to detail.