Manufacturing Specialist- 35599

Location: Juncos, Puerto Rico

Work Schedule: On-site | Administrative Shift

Availability to work different shifts and weekends based on business needs.

Employment Type: Contract: 5 months

Important Notice: This opportunity is available only to individual candidates. Third-party agencies, staffing firms, vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Position Summary

Our client is seeking a Manufacturing Specialist to support manufacturing operations with minimal supervision. The selected candidate will be responsible for executing and supporting manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.

This role requires strong technical knowledge, analytical thinking, troubleshooting skills, and a solid understanding of manufacturing compliance. The Manufacturing Specialist may also serve as the primary process owner for assigned manufacturing support systems while assisting with more complex manufacturing processes.

Key Responsibilities

Manufacturing Process Support

• Initiate, revise, and approve manufacturing procedures, ensuring documentation accurately reflects current operations.
• Serve as the document owner for assigned manufacturing procedures.
• Monitor manufacturing processes through floor observations and performance data analysis.
• Identify opportunities for process improvements and implement effective solutions.
• Provide technical troubleshooting support to manufacturing operations.
• Assist in developing training materials and deliver technical or scientific process training as needed.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Assist in the evaluation of process deviations.
• Support the timely preparation and completion of quarterly process monitoring reports.

Non-Conformance (NC) & CAPA Management

• Ensure all non-conformances are triaged within established timelines.
• Author investigation reports for non-conformance events.
• Execute corrective and preventive actions (CAPAs).
• Manage NC/CAPA activities through closure within established deadlines.
• Monitor, analyze, and communicate process and incident trends.
• Review Root Cause Analysis investigations for equipment and systems and support trend evaluations.

Process Validation

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

Regulatory & Compliance Support

• Participate in regulatory inspections, audits, and compliance activities.
• Support New Product Introductions (NPI) by assessing documentation, training, material, and equipment requirements.
• Assist in evaluating, prioritizing, and implementing process and equipment modification projects.
• Provide project management support for manufacturing improvement initiatives.

Change Control

• Support Manufacturing Change Owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.

Projects & Continuous Improvement

• Participate in special projects and continuous improvement initiatives.
• Perform additional duties as assigned.

Minimum Qualifications

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

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

Required Qualifications & Skills

• Experience with bioprocessing unit operations.
• Strong understanding of GMP (Good Manufacturing Practices) production operations.
• Knowledge of process validation and manufacturing process monitoring.
• Experience managing non-conformances, investigations, and CAPAs.
• Familiarity with regulatory requirements in a regulated manufacturing environment.
• Knowledge of Root Cause Analysis methodologies, including:
• Fishbone Diagram
• 5 Whys
• Kepner-Tregoe
• Six Boxes
• Experience with Lean Manufacturing principles.
• Proficiency in Good Documentation Practices (GDP).
• Experience working with manufacturing and quality systems, including:
• TrackWise
• Veeva
• MES
• SmartSheet
• Power BI
• Spotfire
• CDOCS
• Process Monitoring Platforms
• Microsoft Copilot
• ChatGPT
• Basic knowledge of statistical process control and control charting.
• Basic project management skills.
• Strong technical writing and presentation skills.
• Excellent verbal and written communication skills in both English and Spanish.
• Strong organizational and analytical skills.
• Ability to collaborate effectively with cross-functional teams, including Manufacturing, Process Development, Quality, and Technical Operations.
• Excellent interpersonal and teamwork skills.
• Ability to work independently with minimal supervision.
• Ability to perform effectively in a fast-paced, high-volume environment.
• Willingness to work extended hours, alternate shifts, weekends, and overtime as business needs require.