Manufacturing Specialist 35596

Title: Manufacturing Specialist – Job

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.

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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…