Title: Manufacturing Specialist 35625

Location: Juncos, Puerto Rico

Eligibility: Puerto Rico residents only

Work Schedule: Onsite, 8-hour administrative shift | 8:00 AM–5:00 PM

Overtime: May be required based on business needs

Positions Available: 1

Contract Duration: 6 months

Position Summary

The Manufacturing Specialist will support manufacturing and quality systems with minimal supervision in a highly regulated biotechnology manufacturing environment. The role will apply process, operational, and scientific expertise to support manufacturing operations, maintain compliance, troubleshoot process issues, and drive continuous improvement.

The selected candidate may serve as the primary process owner for assigned production support systems and provide support for more complex process systems.

Preferred Qualifications

• Experience with document management using Veeva Vault (CDOCS) or similar platforms.
• Strong technical writing and documentation skills.
• Experience with Change Control, preferably as a change owner.
• Experience supporting projects and process improvement initiatives.
• Proficiency with Smartsheet or similar project and workflow management platforms.

Key Responsibilities

Process Expertise & Manufacturing Support

• Initiate, revise, review, and approve manufacturing procedures, ensuring documentation accurately reflects current operations.
• Serve as a document owner for assigned manufacturing procedures and support documentation lifecycle activities.
• Assess manufacturing process performance through floor observations and review of process data.
• Identify, evaluate, and implement opportunities for process improvement.
• Provide technical troubleshooting support for manufacturing processes.
• Assist in developing technical and training materials.
• Support training activities related to scientific and technical aspects of manufacturing processes.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Support the assessment of process deviations and manufacturing performance trends.
• Support the timely preparation and completion of quarterly process monitoring reports.

Non-Conformance & CAPA Management

• Ensure non-conformances are appropriately triaged within established timelines.
• Author investigation reports and support manufacturing event investigations.
• Execute corrective and preventive actions (CAPAs).
• Manage NC/CAPA activities through timely closure.
• Monitor and communicate incident trends.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.

Process Validation

• Assist with the development of process validation protocols and reports.
• Support the execution of process validation activities.
• Collect, analyze, and document process validation data.

Regulatory Compliance & New Product Introduction

• Support regulatory inspections and compliance activities as required.
• Participate in New Product Introduction (NPI) activities.
• Assess documentation, material, training, and equipment requirements associated with NPI activities.
• Support process and equipment modification projects.
• Assess, prioritize, justify, and support the implementation of process or equipment modifications.
• Provide project coordination and management support as required.

Change Control

• Support Manufacturing Change Owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
• Assist with the coordination and documentation of manufacturing-related changes.

Projects & Continuous Improvement

• Participate in the assessment and implementation of special projects and manufacturing initiatives.
• Support continuous improvement and operational excellence activities.
• Perform other duties and responsibilities as assigned.

Education & Experience

Candidates must meet one of the following combinations:

• Doctorate degree
• Master's degree plus 2 years of Manufacturing Operations experience
• Bachelor's degree plus 4 years of Manufacturing Operations experience
• Associate degree plus 8 years of Manufacturing Operations experience
• High School Diploma/GED plus 10 years of Manufacturing Operations experience

Required Skills & Competencies

• Detailed technical understanding of bioprocessing unit operations.
• Experience supporting GMP manufacturing operations.
• Knowledge of regulatory requirements and compliance practices.
• Ability to participate in and support cross-functional teams.
• Strong communication and collaboration skills with Manufacturing, Process Development, Quality, and technical/management teams.
• Strong organizational, technical writing, and presentation skills.
• Basic project management knowledge.
• Basic understanding of control charting and process monitoring.