Manufacturing Specialist – PROQN-716

Location: Juncos, Puerto Rico

Work Schedule: Onsite – Administrative Shift

Availability: Candidates must be available to support different shifts as business needs require.

Position Available: 1

6 months contract

Important Notice

This opportunity is available only to individual candidates. Submissions from third-party contractors, staffing agencies, vendors, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a Manufacturing Specialist to support manufacturing operations with minimal supervision. The selected candidate will support the execution of manufacturing and quality systems, including Non-Conformances (NCs), process validation, manufacturing procedures, training, and New Product Introductions (NPI).

The ideal candidate will apply strong process and operational knowledge, scientific expertise, analytical thinking, compliance awareness, and troubleshooting skills to support manufacturing operations and improve process performance.

This position may serve as the primary process owner for assigned manufacturing support systems and assist with process ownership responsibilities for more complex manufacturing processes.

Key Focus Areas

• Strong manufacturing operations experience is required; this role is focused on manufacturing rather than a primarily Quality-based position.
• Experience with document management, including creating, revising, reviewing, and approving manufacturing documents.
• Ability to work directly with manufacturing operators and provide hands-on technical support on the manufacturing floor.

Key Responsibilities

Applied Process Expertise

• Initiate, revise, review, and approve manufacturing procedures, ensuring documentation accurately reflects current manufacturing operations.
• Serve as the document owner for assigned manufacturing procedures and support the document lifecycle.
• Assess process performance through floor observations and analysis of manufacturing performance data.
• Identify process improvement opportunities and evaluate, plan, and implement effective solutions.
• Provide technical troubleshooting support to manufacturing operations.
• Assist with the development of training materials and, as needed, provide training on 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 and support the evaluation of process deviations.
• Support the timely preparation and execution of quarterly process monitoring reports.

Non-Conformance & CAPA

• Ensure Non-Conformances (NCs) are triaged within established timelines.
• Author investigation reports for manufacturing-related events and Non-Conformances.
• Execute corrective actions and support their timely implementation.
• Manage NC and CAPA activities through closure within established timelines.
• Monitor, analyze, and communicate manufacturing incident trends.
• Review Root Cause Analysis (RCA) investigations related to equipment and manufacturing systems and support trend evaluations.

Process Validation

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

Regulatory & Manufacturing Support

• Participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modification activities, as needed.
• Participate in the NPI process by assessing requirements related to documentation, materials, training, and equipment modifications.
• Evaluate, prioritize, and provide technical justification for process or equipment modification projects.
• Provide implementation and project management support for manufacturing process and equipment modifications.

Change Control

• Support Manufacturing Change Owners in preparing and coordinating Change Control Review Board (CCRB) packages impacting manufacturing processes.

Projects & Initiatives

• Participate in the assessment and implementation of special projects, manufacturing initiatives, and continuous improvement activities.
• Support cross-functional initiatives that improve manufacturing performance, compliance, and process reliability.
• Perform other duties and responsibilities as assigned.

Education & Experience

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

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

Required Competencies & Skills

• Strong technical understanding of bioprocessing unit operations.
• Hands-on experience supporting GMP manufacturing operations.
• Working knowledge of applicable regulatory requirements and experience participating in regulatory interactions.
• Ability to participate in and contribute to cross-functional teams.
• Strong communication and collaboration skills when working with technical and management personnel across Manufacturing, Process Development, and Quality.
• Strong organizational, technical writing, documentation, and presentation skills.
• Basic project management knowledge and experience.
• Basic understanding of statistical process monitoring and control charting.
• Ability to work effectively with manufacturing operators and technical personnel in a fast-paced production environment.