Principal Process Scientist

ProQuality Network; United States; Hybrid; USD 83,000 - 138,000; Part time

Job summary

ProQuality Network is seeking a Technical Contractor SME to provide specialized support for sterile manufacturing operations at the Manatí site. The role focuses on process science and parenteral inspection technologies to enable ongoing manufacturing, tech transfer, and continuous improvement.

The candidate will work cross-functionally with Manufacturing, Engineering, Quality and Validation to ensure regulatory compliance and alignment with site priorities.

Qualifications

• Expertise in process science and parenteral inspection technologies for sterile manufacturing.
• Strong problem-solving skills and experience in pharmaceutical sterile environments.
• Ability to collaborate with Manufacturing, Engineering, Quality, and Validation teams.
• Knowledge of cGMP and regulatory expectations.

Responsibilities

• Provide specialized technical support for sterile manufacturing operations.
• Serve as Subject Matter Expert for sterile manufacturing processes.
• Support manufacturing of liquid and lyophilized parenteral products.
• Provide day-to-day support for manufacturing operations.
• Perform technical troubleshooting activities.
• Support investigations including deviations and CAPAs.
• Participate in process validation activities.
• Contribute to technology transfer efforts.
• Support process optimization initiatives.
• Collaborate with cross-functional teams to meet objectives.
• Ensure compliance with cGMP and site procedures.

Skills

Process science

Parenteral inspection technologies

Sterile manufacturing

Cross-functional collaboration

Problem-solving

Regulatory compliance

Job description

Positions Available:

1 Technical Contractor

Position Summary

Our client is seeking one Technical Contractor to provide specialized support for Sterile Manufacturing Operations at the Manatí site.

The scope of work requires expertise in process science and parenteral inspection technologies to support ongoing manufacturing operations, technology transfer activities, and continuous improvement initiatives.

The selected candidate will serve as a Subject Matter Expert (SME) for sterile manufacturing processes involving both liquid and lyophilized parenteral products. This individual will collaborate cross-functionally with Manufacturing, Engineering, Quality, and Validation teams to ensure alignment with site priorities and regulatory requirements. Strong technical expertise, problem-solving skills, and experience in pharmaceutical sterile manufacturing environments are essential.

Key Responsibilities

• Provide specialized technical support for sterile manufacturing operations.
• Serve as a Subject Matter Expert (SME) for sterile manufacturing processes.
• Support manufacturing of liquid and lyophilized parenteral products.
• Provide day-to-day support for manufacturing operations.
• Perform technical troubleshooting activities.
• Support investigations, including deviations and CAPAs.
• Participate in process validation activities.
• Contribute to technology transfer efforts.
• Support process optimization initiatives.
• Collaborate with Manufacturing, Engineering, Quality, and Validation teams to support operational objectives.
• Ensure compliance with current Good Manufacturing Practices (cGMP) and site procedures.