Title: Manufacturing Specialist – Job ID 35596

Location: Puerto Rico (Local Residents Only)

Work Schedule: Hybrid | Monday – Friday | 8:00 a.m. – 5:00 p.m.

On-Call Requirement: Flexibility to provide on-call support as needed.

Position Summary

Our client is seeking a Manufacturing Specialist to support manufacturing operations and quality systems in a regulated biopharmaceutical environment. This role is responsible for driving process improvements, supporting manufacturing investigations, maintaining compliance, and collaborating with cross-functional teams to ensure safe, efficient, and compliant production.

The ideal candidate combines technical expertise in manufacturing processes with strong analytical, problem-solving, and communication skills to support process validation, new product introductions, continuous improvement initiatives, and operational excellence.

Key Responsibilities

Manufacturing & Process Support

• Support manufacturing operations by providing technical expertise and troubleshooting process-related issues.
• Serve as a process support resource for manufacturing systems and assist with process ownership activities.
• Lead or support manufacturing process changes through the Change Control process.
• Evaluate manufacturing performance and recommend process improvements based on operational data and observations.
• Provide commercial manufacturing support and assist with floor operations as needed.
• Support campaign readiness activities and collaborate with cross-functional teams to ensure successful execution.

Quality Systems & Compliance

• Lead or support deviation investigations throughout the complete lifecycle, including:
• Root Cause Analysis (RCA)
• Impact assessments
• Corrective and Preventive Actions (CAPAs)
• Investigation report authoring
• Support during regulatory inspections
• Perform risk assessments and microbial impact evaluations.
• Ensure timely triage, investigation, execution, and closure of non-conformances and CAPAs.
• Monitor, analyze, and communicate process and incident trends.
• Review equipment and system investigations and support trend analysis.

Process Validation & Technical Support

• Support the development and execution of process validation protocols and reports.
• Collect, analyze, and evaluate validation data.
• Design, coordinate, and support functional testing, water testing, engineering runs, and other process qualification activities.
• Generate technical protocols and supporting documentation as required.
• Evaluate process, automation, and equipment modifications and support implementation of special projects.

Documentation & Training

• Create, revise, review, and approve manufacturing procedures and controlled documents.
• Serve as a document owner to ensure procedures accurately reflect current operations.
• Assist in the creation of Master Batch Records (MBRs) and revisions.
• Develop technical training materials and provide scientific or process-related training when required.
• Ensure compliance with Good Documentation Practices (GDP) in a regulated manufacturing environment.

Process Monitoring & Continuous Improvement

• Support the establishment of process monitoring parameters and control limits.
• Analyze manufacturing data and prepare process monitoring reports.
• Identify improvement opportunities and implement corrective actions to enhance process performance.
• Complete CAPA applicability assessments for other manufacturing sites.
• Evaluate new or revised Bills of Materials (BOMs) to support manufacturing changes.

Regulatory & Project Support

• Participate in regulatory inspections and audits as required.
• Support New Product Introduction (NPI) activities, including documentation, equipment, training, and material readiness.
• Assist with process and equipment modification projects from planning through implementation.
• Participate in cross-functional initiatives and continuous improvement projects.

Preferred Qualifications

• Educational background in Life Sciences, Engineering, or a related technical discipline.
• Hands-on experience supporting biopharmaceutical manufacturing operations, including:
• Cell Culture
• Drug Substance Purification
• Strong knowledge of Root Cause Analysis methodologies, including:
• Fishbone (Ishikawa)
• 5 Whys
• Kepner-Tregoe
• Six Boxes
• Experience with Lean Manufacturing principles and continuous improvement methodologies.
• Working knowledge of Good Documentation Practices (GDP) and GMP regulations.
• Experience using manufacturing and quality systems such as:
• TrackWise
• Spotfire
• CDOCS
• Process Monitoring platforms
• Strong technical writing, presentation, and documentation skills.
• Excellent verbal and written communication skills in both English and Spanish.
• Ability to collaborate effectively with Manufacturing, Process Development, Engineering, and Quality teams.

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

Required Knowledge & Skills

• Strong understanding of bioprocess manufacturing operations.
• Experience working in GMP-regulated manufacturing environments.
• Knowledge of manufacturing investigations, CAPAs, process validation, and change control.
• Familiarity with regulatory requirements and inspection readiness.
• Ability to analyze manufacturing data and identify process improvement opportunities.
• Experience participating in cross-functional teams and technical projects.
• Strong organizational, analytical, and problem-solving skills.
• Technical writing and presentation experience.
• Basic project management knowledge.
• Familiarity with statistical process monitoring and control charting.