Title: Specialist Manufacturing ProQN922

Location: Juncos, Puerto Rico (Puerto Rico residents only)

Work Arrangement: On-site, Administrative Shift

Number of Positions: 3

1 year contract

Summary

With minimal supervision, support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. 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 operations experience.
• Experience with CAPAs, Change Control (CC), Risk Assessments, and CDOC Editor.

Functions and Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations.
• Serve as a document owner.
• Assess process performance through floor observations and performance data reviews.
• Evaluate, plan, and implement solutions to process improvement opportunities.
• Provide troubleshooting support.
• Assist in developing 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 timelines.
• Author investigation reports.
• Execute corrective actions.
• Manage non-conformance (NC) and CAPA closures within established timelines.
• Monitor and communicate incident trends.
• Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.

Process Validation

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

Regulatory

• May participate in regulatory inspections.

New Product Introductions and Process or Equipment Modifications

• Participate in the New Product Introduction (NPI) process to assess documentation, material, training, and equipment modification requirements.
• Assess, prioritize, and justify process or equipment modification projects.
• Provide implementation and project management support for these projects.

Change Control

• Assist the manufacturing change owner with Change Control Review Board (CCRB) packages that impact the process.

Projects and Initiatives

• Participate in the assessment or implementation of special projects or initiatives.

Other functions may be assigned.

Education and Experience Requirements

Candidates must meet one of the following requirements:

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

Competencies and Skills

• Detailed technical understanding of bioprocessing unit operations.
• Proficiency in GMP production operations.
• Regulatory knowledge and experience with regulatory interactions.
• Ability to participate in and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff across manufacturing, process development, and quality.
• Strong organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.