Manufacturing Process Owner ProQN686

Job Description

Job Description

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 .