Title: Manufacturing Process Owner ProQN686

Industry: Pharmaceutical

Location: Juncos, Puerto Rico (Open only to Puerto Rico Residents)

Work Schedule: Onsite | Administrative Shift

Contract Duration: 6 months

Positions Available: 1

Summary

Our client is seeking a Manufacturing Process Owner to support manufacturing and quality systems with minimal supervision. The role will provide process, operational, scientific, and troubleshooting expertise across areas such as non-conformances, CAPA, process validation, procedures, training, process monitoring, and New Product Introductions (NPI).

The selected candidate may serve as the primary process owner for production support systems and assist with more complex process ownership activities.

Preferred Qualifications

• Knowledge of document management using Veeva Vault (CDOCs) or similar platforms.
• Strong technical writing skills.
• Experience managing Change Controls as an owner.
• Project management experience.
• Experience using Smartsheet or a similar project management platform.
• Detailed technical understanding of bioprocessing unit operations.

Key Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring documentation reflects current operations.
• Serve as a document owner and support effective document management.
• Evaluate process performance through floor observations and review of performance data.
• Identify and implement process improvement opportunities.
• Provide technical troubleshooting support.
• Develop training materials and support training on scientific and technical process topics.

Process Monitoring

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

Non-Conformance & CAPA

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

Process Validation

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

Regulatory, NPI & Process/Equipment Modifications

• Participate in regulatory inspections, New Product Introductions, and process or equipment modifications, as needed.
• Support NPI activities by assessing documentation, materials, training, and equipment modification requirements.
• Assess, prioritize, justify, and support the implementation and project management of process or equipment modification projects.

Change Control

• Support manufacturing Change Control owners with CCRB packages impacting the process.

Projects & Initiatives

• Participate in the assessment and implementation of special projects and business initiatives.

Other duties may be assigned based on business needs.

Education & Experience

• Doctorate, 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.

Competencies & Skills

• Detailed technical understanding of bioprocessing unit operations.
• Demonstrated ability to perform GMP manufacturing operations.
• Working knowledge of regulatory requirements and regulatory interactions.
• Ability to participate in and help lead cross-functional teams.
• Strong communication and collaboration skills with teams across Manufacturing, Process Development, Quality, and technical/management functions.
• Strong organizational, technical writing, and presentation skills.
• Basic project management knowledge and skills.
• Basic knowledge of control charting.