Title: Specialist Manufacturing ProQN829

Location: Juncos, PR — Only open to Puerto Rico Residents

Work Schedule: Onsite, Administrative Shift; availability to cover other shifts based on business needs

Positions Available: 2

Summary

Our client is seeking a Specialist Manufacturing professional to support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and New Product Introductions (NPI).

With minimal supervision, the Specialist applies process, operational, and scientific expertise, along with basic compliance knowledge and analytical and troubleshooting skills, to support manufacturing operations. The role may serve as the primary production process owner for process support systems and assist with process ownership responsibilities for more complex process systems.

Preferred Qualifications

• Manufacturing experience.
• Experience providing on-the-floor support and assessing process performance through observation of floor operations and review of performance data.
• Experience initiating, revising, and approving manufacturing procedures.
• Experience providing process troubleshooting support.
• Experience participating in New Product Introduction (NPI) activities, including assessment of documentation, materials, and training requirements.
• Experience assisting manufacturing change owners with CCRB packages impacting processes.
• Experience participating in the assessment or implementation of special projects or initiatives.

Education

One of the following:

• Doctorate; or
• Master's degree + 2 years of Manufacturing Operations experience; or
• Bachelor's degree + 4 years of Manufacturing Operations experience; or
• Associate's degree + 8 years of Manufacturing Operations experience; or
• High school diploma/GED + 10 years of Manufacturing Operations experience.

Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures and ensure they accurately reflect current operations.
• Serve as a document owner.
• Assess process performance through observation of floor operations and review of performance data.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide process troubleshooting support.
• Assist in generating training materials and may provide training on scientific or technical aspects of the process.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect process monitoring data and support deviation assessments.
• Support the timely execution of quarterly process monitoring reports.

Non-Conformance and CAPA

• Ensure non-conformances are triaged within established goals.
• Author investigation reports.
• Execute corrective actions.
• Manage NC/CAPA closure within established goals.
• Monitor and communicate incident trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation

• Assist with the generation of process validation protocols and reports.
• Assist with process validation execution.
• Support the collection and analysis of process validation data.

Regulatory and New Product Introduction

• May participate in regulatory inspections, New Product Introductions, and process or equipment modifications.
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control

• Assist manufacturing change owners with CCRB packages impacting the process.

Projects and Initiatives

• Participate in the assessment or implementation of special projects and initiatives.
• Perform other functions as assigned.

Competencies and Skills

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in the performance of GMP production operations.
• Knowledge of regulatory requirements and interactions.
• Ability to participate in and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality.
• Strong organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.