Manufacturing Specialist 35419

Title: Manufacturing Specialist | Job ID: 35419

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

Work Schedule: Onsite | Administrative Shift

Position Type: 6-Month Contract

Openings: 1

Position Summary

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

This role is responsible for supporting the execution of manufacturing and quality processes, including non-conformances, process validation, procedural updates, training activities, and new product introductions (NPI). The selected candidate will apply scientific, technical, and operational expertise to support manufacturing performance, improve processes, and ensure compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.

The ideal candidate will possess strong analytical, troubleshooting, and problem-solving skills, with the ability to collaborate effectively across multiple departments to drive continuous improvement initiatives and support manufacturing excellence.

Preferred Qualifications

• Bachelor's degree with 4+ years of pharmaceutical or biotechnology manufacturing operations experience.
• Experience initiating, revising, and approving manufacturing procedures while serving as a document owner.
• Ability to assess process performance through floor observations and data analysis to identify and implement process improvement opportunities.
• Experience developing training materials and supporting technical or scientific training initiatives.
• Working knowledge of cGMP regulations and other applicable regulatory requirements.
• Experience identifying, assessing, and mitigating risks to ensure product safety, purity, quality, and operational efficiency.
• Familiarity with Electronic Batch Records (EBR) and ensuring alignment with current manufacturing processes.
• Experience supporting process validation protocol generation, execution, and reporting activities.
• Exposure to regulatory inspections and audit support activities.
• Experience supporting New Product Introduction (NPI) initiatives, including documentation, training, materials, and equipment modifications.
• Ability to support process or equipment modification projects from assessment through implementation.
• Experience owning and managing Change Controls to ensure timely implementation.
• Familiarity supporting Change Control Review Board (CCRB) packages impacting manufacturing processes.
• Experience participating in non-commercial manufacturing runs to support process data collection and analysis.
• Ability to support special projects and continuous improvement initiatives.

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 operations and assess process performance through floor observations and performance data analysis.
• Identify, evaluate, and implement process improvement opportunities to enhance operational efficiency.
• Provide technical troubleshooting support for manufacturing operations.
• Develop and support technical and scientific training materials for manufacturing personnel.
• Ensure all manufacturing processes and procedures comply with cGMP requirements and applicable regulations.
• Identify, assess, and mitigate risks to ensure product safety, purity, quality, and process efficiency.
• Ensure Electronic Batch Records (EBRs) remain aligned with current manufacturing processes and support user training as needed.

Process Monitoring Responsibilities

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

Non-Conformance (NC) and CAPA Management

• Ensure all non-conformances are properly 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.
• Manage NC and CAPA closures within established deadlines.
• Monitor, analyze, and communicate incident trends.
• Review Root Cause Analysis (RCA) investigations and support trend evaluations for equipment and systems.

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 compliance and process reliability.

Regulatory Support & New Product Introduction (NPI)

• Participate in regulatory inspections and audit preparation activities.
• Support New Product Introduction (NPI) initiatives by assessing requirements related to:
• Documentation
• Materials
• Training
• Equipment modifications
• Collaborate with cross-functional teams to support implementation activities and project execution.

Change Control Management

• Own and manage Change Controls to ensure implementation within established timelines.
• Support manufacturing change owners with CCRB packages impacting manufacturing processes.
• Monitor and track change implementation activities to ensure successful execution.

Projects & Continuous Improvement

• Participate in the assessment, planning, and implementation of special projects and operational initiatives.
• Support continuous improvement efforts to enhance manufacturing performance and compliance.
• 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 Skills

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

Manufacturing & Quality Systems

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

Project Management & Communication Skills

• Basic project management skills.
• Strong organizational skills.
• Technical writing capabilities.
• Effective presentation skills.
• Ability to communicate clearly with both technical and management teams.
• Ability to manage multiple priorities in a fast-paced environment.

Collaboration & Leadership Skills

• Ability to participate in and support cross-functional teams.
• Strong collaboration skills across Manufacturing, Quality, and Process Development organizations.
• Ability to build effective working relationships with stakeholders at all levels.
• Strong decision-making and problem-solving abilities.