Title: Manufacturing Specialist | Job ID: 35466

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

Work Schedule: Onsite | Administrative Shift

Position Type: 1-Year Contract

Openings: 1

Position Summary

Our client is seeking an experienced Manufacturing Specialist to support manufacturing operations and quality systems within a highly regulated biotechnology and pharmaceutical environment.

This role will support the execution of manufacturing and quality processes, including non-conformances, process validation, procedural updates, training activities, and New Product Introduction (NPI) initiatives. The selected candidate will apply scientific, technical, and operational expertise, along with analytical and troubleshooting skills, to drive manufacturing performance, ensure compliance, and support continuous improvement efforts.

The ideal candidate will have experience supporting Drug Substance manufacturing operations, a strong understanding of GMP manufacturing systems, and the ability to collaborate effectively with cross-functional teams in a fast-paced, highly regulated environment.

Preferred Qualifications

• Experience supporting biotechnology and pharmaceutical manufacturing processes, particularly Drug Substance operations.
• Working knowledge of GMP pharmaceutical manufacturing systems.
• Experience using SAP, TrackWise, PAS-X Electronic Batch Records (EBR), and Veeva document management systems.
• Strong analytical, troubleshooting, and problem-solving skills.
• Experience supporting manufacturing operations in highly regulated environments.
• Ability to work effectively with cross-functional teams and multiple stakeholders.
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Key Responsibilities

Manufacturing Process Support

• Initiate, revise, and approve manufacturing procedures to ensure all documentation accurately reflects current operations.
• Serve as a document owner and maintain compliance with documentation requirements.
• Monitor manufacturing floor operations and assess process performance through direct observations and performance data analysis.
• Identify, evaluate, and implement process improvement opportunities to enhance operational efficiency and reliability.
• Provide technical troubleshooting support for manufacturing processes and equipment.
• Assist in the development of training materials and support technical and scientific training activities for manufacturing personnel.
• Support manufacturing operations while ensuring compliance with GMP requirements and applicable regulations.
• May serve as the primary production process owner for process support systems and assist with more complex process ownership responsibilities.

Process Monitoring Responsibilities

• Support the establishment of process monitoring parameters and control limits.
• Collect process monitoring data and support the evaluation of process deviations.
• Assist in the timely preparation and execution of quarterly process monitoring reports.
• Analyze process performance data and communicate findings to relevant stakeholders.

Non-Conformance (NC) & CAPA Management

• Ensure all non-conformances are appropriately triaged and managed within established timelines.
• Author investigation reports related to manufacturing events and deviations.
• Execute corrective and preventive actions (CAPAs) to address identified issues and prevent recurrence.
• Manage NC and CAPA closure activities to meet established goals.
• Monitor, analyze, and communicate incident trends.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.

Process Validation Responsibilities

• Support the development of process validation protocols and reports.
• Assist with process validation execution activities.
• Collect, analyze, and interpret process validation data.
• Support validation initiatives to ensure process reliability and regulatory compliance.

Regulatory Support & New Product Introduction (NPI)

• Participate in regulatory inspections and audit support activities, as needed.
• Support New Product Introduction (NPI) initiatives by assessing requirements related to:
• Documentation
• Materials
• Training
• Equipment modifications
• Assess, prioritize, justify, and support implementation activities for process or equipment modification projects.
• Collaborate with cross-functional teams to ensure successful project execution.

Change Control Responsibilities

• Support manufacturing change owners with Change Control Review Board (CCRB) packages that impact manufacturing processes.
• Assist with the implementation and tracking of change management activities.

Projects & Continuous Improvement

• Participate in the assessment, planning, and implementation of special projects and operational initiatives.
• Support continuous improvement efforts to enhance manufacturing performance, compliance, and operational efficiency.
• Perform additional duties as assigned.

Education Requirements

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

• 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 degree with 8+ years of Manufacturing Operations experience; OR
• High School Diploma/GED with 10+ years of Manufacturing Operations experience.

Required Skills & Competencies

Technical & Manufacturing Skills

• Strong technical understanding of bioprocessing unit operations.
• Experience performing GMP manufacturing operations.
• Knowledge of regulatory requirements and regulatory interactions.
• Familiarity with manufacturing process support activities.
• Experience supporting process validation activities.
• Basic knowledge of statistical process control and control charting.
• Strong technical troubleshooting and analytical problem-solving skills.

Manufacturing & Quality Systems

• Non-Conformance (NC) Management
• CAPA Management
• Root Cause Analysis (RCA)
• Process Monitoring
• Process Validation
• Documentation Management
• New Product Introduction (NPI)
• Change Control Support
• Electronic Batch Records (EBR)
• Risk Assessment and Mitigation

Systems & Software

• SAP
• TrackWise
• PAS-X Electronic Batch Records (EBR)
• Veeva Document Management Systems

Communication & Project Management Skills

• Strong organizational skills.
• Technical writing capabilities.
• Effective presentation skills.
• Basic project management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong verbal and written communication skills.

Collaboration & Leadership Skills

• Ability to participate in and support cross-functional teams.
• Strong collaboration skills across Manufacturing, Quality, and Process Development organizations.
• Ability to communicate effectively with technical and management personnel.
• Strong interpersonal and relationship-building skills.
• Ability to work independently while maintaining a collaborative mindset.