Title: Manufacturing Specialist – Job ID 35510
Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)
Positions Available: 4
Work Schedule: Onsite | Administrative Shift (8-hour shift)
Contract Duration: 1 Year
Work Schedule Requirements: Availability to work overtime based on business needs.
Position Summary
Our client is seeking a Manufacturing Specialist to support manufacturing and quality operations with minimal supervision. The selected candidate will contribute to the execution of quality systems, including non-conformance management, process validation, procedures, training, and New Product Introduction (NPI) activities.
This role requires the application of manufacturing, scientific, and operational knowledge to support daily manufacturing operations through process monitoring, troubleshooting, investigations, continuous improvement initiatives, and regulatory compliance. The Manufacturing Specialist may also serve as the process owner for assigned manufacturing systems while supporting more complex production processes.
Preferred Qualifications
- Bachelor's degree in Engineering is preferred.
- Experience in biotechnology and pharmaceutical manufacturing environments.
- Experience with deviation management and deviation assessments.
- Experience using TrackWise.
- Knowledge of manufacturing quality systems and GMP operations.
Key Responsibilities
Manufacturing Process Support
- Initiate, revise, review, and approve manufacturing procedures while ensuring documentation accurately reflects current manufacturing operations.
- Serve as the document owner for assigned manufacturing procedures.
- Evaluate manufacturing process performance through floor observations and analysis of operational data.
- Identify opportunities for process improvements and support implementation of corrective actions.
- Provide technical troubleshooting support for manufacturing processes and equipment.
- Assist in the development of technical training materials and support training activities for manufacturing personnel.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect, review, and analyze process monitoring data.
- Support deviation assessments through process data analysis.
- Assist with the timely preparation and execution of quarterly process monitoring reports.
Non-Conformance Management & CAPA
- Ensure non-conformances are triaged within established timelines.
- Author investigation reports for manufacturing and quality events.
- Execute Corrective and Preventive Actions (CAPA).
- Manage non-conformance and CAPA records through timely closure.
- Monitor and communicate manufacturing incident trends.
- Review equipment and system Root Cause Analysis (RCA) investigations and support trend analysis activities.
Process Validation
- Assist with the development of process validation protocols and reports.
- Support execution of process validation activities.
- Collect, analyze, and interpret validation data to support manufacturing processes.
Regulatory Compliance
- Participate in regulatory inspections, as required.
- Support New Product Introduction (NPI) initiatives by evaluating documentation, materials, training requirements, and equipment modifications.
- Assess, prioritize, justify, and support implementation of process and equipment modification projects.
- Ensure manufacturing activities comply with GMP requirements, internal procedures, and regulatory expectations.
Change Control
- Support the Manufacturing Change Owner with Change Control Review Board (CCRB) packages affecting manufacturing processes.
Projects & Continuous Improvement
- Participate in special projects and continuous improvement initiatives.
- Support implementation of manufacturing and operational improvement projects.
- Perform additional duties as assigned.
Minimum Education & Experience
Candidates must meet one of the following qualifications:
- Doctorate degree
OR
- Master's degree with 2 years of Manufacturing Operations experience
OR
- Bachelor's degree with 4 years of Manufacturing Operations experience
OR
- Associate's degree with 8 years of Manufacturing Operations experience
OR
- High School Diploma/GED with 10 years of Manufacturing Operations experience
Required Skills
Manufacturing & Technical Skills
- Manufacturing Operations
- Bioprocessing Unit Operations
- GMP Manufacturing Operations
- Process Monitoring
- Process Validation
- Process Troubleshooting
- Manufacturing Process Improvement
- New Product Introduction (NPI)
- Process Data Collection and Analysis
- Root Cause Analysis (RCA)
- Control Chart Fundamentals
Quality Systems
- Non-Conformance Management
- CAPA Execution
- Deviation Management
- Deviation Assessments
- Investigation Report Writing
- Change Control
- TrackWise
- Regulatory Compliance
- Equipment and System Investigations
Documentation & Communication
- Technical Writing
- Manufacturing Procedures
- Document Ownership
- Report Preparation
- Organizational Skills
- Presentation Skills
- Verbal and Written Communication
Collaboration & Leadership
- Cross-Functional Team Collaboration
- Manufacturing Support
- Quality Support
- Process Development Collaboration
- Project Management
- Continuous Improvement
- Regulatory Inspection Support
Preferred Technical Knowledge
- Biotechnology Manufacturing
- Pharmaceutical Manufacturing
- Regulatory Requirements and Compliance
- Manufacturing Quality Systems
- Scientific and Analytical Problem Solving