External Senior Process Engineer

Liquidia

About The Position

The External Senior Process Engineer with packaging expertise will take part in production activities conducted with our external manufacturing partners that include planning, tech. transfer, and GMP manufacturing oversight. The person will have excellent project planning and communication with internal and external partners and be able to travel up to 20% to support production activities. They will ensure the highest level of quality and compliance in all activities, review and approve batch records, manage change controls, and resolve investigations.

Requirements

BS degree in a technical field
5+ year of manufacturing management experience in a cGMP environment supporting external operations.
Direct experience with packaging and labeling.
Knowledge of encapsulation and/or liposome production process.
Excellent communication including the ability to seek, accept and provide constructive feedback.
Ability to align internal and external teams on external manufacturing goals ensuring timely support and release of our drug products.
Demonstrated background in technical problem solving, tech. transfers and continuous improvement.
Mechanical aptitude with solid understanding of general equipment operation including encapsulation and blister packaging.
Technical knowledge and oversight of primary and secondary packaging including blister packaging, blow-fill-seal, commercial labeling and serialization. Ability to support other production steps including encapsulation as needed.

Responsibilities

Ensure effective communication and project management across all functions involved in external manufacturing activities.
Lead tech. transfers and scale up manufacturing processes through coordination of technical activities at external manufacturing sites including international and domestic partners.
Review all records, reports ensuring cGMP, quality, and regulatory compliance.
Travel up to 20% (including some international travel) to ensure manufacturing and development activities are completed within timelines and meeting our quality standards.
Identify, troubleshoot, and resolve technical issues associated with manufacturing operations with input from other technical functions.
Identify and implement continuous improvement projects to improve yield, product quality and/or reduce cost
Review and manage Statement of Works, POs to manage external manufacturing budgets.