Specialist Manufacturing (3457427)

Title: Specialist, Manufacturing (3457427)

Location: East Region, Puerto Rico (Open to Puerto Rico residents who are U.S. citizens)

Work Model: 100% Onsite – Non-Standard Shift (8-hour shift; overtime based on business needs)

Contract Type: This position is offered through ProQualityNetwork as a contract assignment supporting our client.

SUMMARY

Under minimal supervision, the Specialist supports the execution of manufacturing and quality systems including non-conformances, process validation, procedures, training, and new product introductions. The role applies process, operational, and scientific expertise, as well as compliance knowledge, analytical skills, and troubleshooting capabilities to support manufacturing operations. The Specialist may serve as a primary process owner for production systems and assist with process ownership responsibilities for more complex operations.

PREFERRED QUALIFICATIONS

• Experience in writing and revising Standard Operating Procedures (SOPs).
• Experience with manufacturing equipment and process operations.
• Ability to develop new SOPs and provide training to manufacturing personnel.

PRIMARY RESPONSIBILITIES

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations.
• Serve as document owner and maintain controlled documentation.
• Assess process performance through observation and data review; recommend and implement process improvements.
• Provide technical and troubleshooting support to manufacturing operations.
• Assist in generating training materials and delivering process-related training sessions.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process-monitoring data, supporting deviation assessments.
• Assist in the timely execution of quarterly process monitoring reports.

Non-Conformance and CAPA Management

• Ensure timely triage and closure of non-conformances (NC) and corrective and preventive actions (CAPA).
• Author investigation reports and execute corrective actions as assigned.
• Monitor and communicate incident trends and perform trend evaluations.
• Review equipment/system root cause analyses.

Process Validation

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

Regulatory Support

• Participate in internal and external regulatory inspections as required.

New Product Introductions & Equipment Modifications

• Support NPI activities by assessing documentation, materials, training, and equipment modification requirements.
• Provide implementation and project management support for process or equipment modifications.

Change Control

• Assist manufacturing change owners with change control review board (CCRB) packages affecting production processes.

Projects and Initiatives

• Participate in the evaluation and execution of special projects or continuous improvement initiatives.

Other functions may be assigned as needed.

EDUCATION / EXPERIENCE

• Doctorate degree OR
• Master’s degree and 3 years of manufacturing operations experience OR
• Bachelor’s degree and 5 years of manufacturing operations experience OR
• Associate’s degree and 10 years of manufacturing operations experience OR
• High school diploma/GED and 12 years of manufacturing operations experience.

COMPETENCIES / SKILLS

• Strong technical understanding of bioprocessing and GMP operations.
• Knowledge of regulatory requirements and inspection processes.
• Effective communication and collaboration across technical and management teams.
• Strong organizational, documentation, and presentation skills.
• Basic project management and control charting knowledge.
• Ability to lead or contribute to cross-functional teams in a dynamic environment.

If you are interested in joining a global leader in biotechnology and contributing to high-quality operations, we invite you to apply through the job description link with your most updated resume for immediate consideration.