Special Manufacturing Specialist – 35529

Location: Juncos, Puerto Rico

Schedule: On-site | Administrative Shift (8-hour shift)

Work Schedule Requirements: Availability to work different shifts, weekends, and overtime based on business needs.

Open Positions: 1

Contract Duration: 1 year

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

Position Summary

Our client is seeking a Special Manufacturing Specialist to support manufacturing operations with minimal supervision. This role is responsible for executing and supporting manufacturing and quality systems, including deviations, non-conformances, process validation, procedures, training, and new product introductions.

The ideal candidate will apply scientific, technical, and operational expertise to support manufacturing processes, ensure compliance with GMP regulations, identify process improvement opportunities, and troubleshoot operational issues. The position may also serve as the primary owner of assigned manufacturing process support systems.

Key Responsibilities

Manufacturing Process Support

• Initiate, revise, review, and approve manufacturing procedures while ensuring documentation reflects current operations.
• Serve as the owner of assigned controlled documents.
• Monitor manufacturing floor operations and evaluate process performance.
• Identify opportunities for process improvements and implement effective solutions.
• Provide technical troubleshooting and manufacturing support.
• Assist in developing training materials and deliver technical process training as needed.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Support deviation assessments and process performance evaluations.
• Prepare and support the timely completion of quarterly process monitoring reports.

Deviations, Non-Conformances (NC), and CAPA

• Ensure all non-conformances are triaged within established timelines.
• Author investigation reports for deviations and non-conformances.
• Execute corrective and preventive actions (CAPA).
• Manage NC/CAPA records through closure within established goals.
• Monitor, analyze, and communicate incident and deviation trends.
• Review equipment and system Root Cause Analysis (RCA) investigations.
• Support trend analysis and continuous improvement initiatives.
• Perform deviation management activities using TrackWise.

Process Validation

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

Regulatory Compliance

• Support regulatory inspections and ensure manufacturing activities remain compliant with GMP requirements.
• Participate in regulatory readiness activities.

New Product Introductions (NPI) & Process Changes

• Participate in New Product Introduction (NPI) projects.
• Assess documentation, material, equipment, and training requirements.
• Support process and equipment modification projects.
• Assist with implementation planning and project execution.

Change Control

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

Projects

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

Preferred Qualifications

• Bachelor's degree in Engineering is highly preferred.
• Biotechnology and manufacturing industry experience.
• Experience managing deviations and investigations.
• Experience performing deviation assessments.
• Experience using TrackWise.
• GMP manufacturing experience within a regulated environment.

Required Skills & Competencies

• Strong technical understanding of bioprocess manufacturing operations.
• Hands-on experience supporting GMP manufacturing processes.
• Knowledge of regulatory requirements and compliance standards.
• Experience participating in cross-functional teams.
• Strong analytical and troubleshooting skills.
• Excellent organizational and technical writing skills.
• Effective verbal and written communication skills.
• Ability to collaborate with Manufacturing, Process Development, Engineering, and Quality teams.
• Basic project management skills.
• Knowledge of statistical process monitoring and control charting.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced manufacturing environment.