Manufacturing Support Engineer

Liquidia

13h•Onsite

About The Position

The Manufacturing Support Engineer works within cross-functional teams to support internal manufacturing operations. Provides technical support to the engineering of novel particles for drug delivery during bulk manufacturing as well as manages manufacturing deviations and CAPA’s. This role is for a 2,2,3 schedule 12-hour shift support - day shift or night shift will be accepted.

Requirements

BS/MS in a technical discipline (Engineering or Life Sciences preferred)
0-2 years (Associate MFG Support Engineer); 2-4 (Sr Associate MFG Support Engineer) 4-8 (MFG Support Engineer); 8+ years (Sr MFG Support Engineer) relevant experience in technical services, operations support or manufacturing sciences in a pharmaceutical setting or current Good Manufacturing Practices (cGMP) regulated environment.
Strong technical problem-solving and hands on troubleshooting skills.
Working knowledge of quality management system elements, including change control, deviation management, and corrective and preventive actions.
Ability to work and communicate effectively within a cross-functional team and across levels within an organization.
Demonstrated ability to work independently and as part of a team
Ability to summarize data and results for business and technical audiences.
Knowledge of Six Sigma/Process Excellence Tools including DoE process capability analysis, pFMEA, fish bone diagrams, statistical analysis
Mechanical aptitude for troubleshooting of production equipment, including automated systems preferred.
Knowledge of FDA cGMP regulations.

Responsibilities

Support manufacturing operations providing on-the-floor troubleshooting and technical support for process and equipment issues.
Own equipment or systems supporting manufacturing operations.
Collaborate, communicate, and suggest direction to internal partners.
Own and/or support Deviations, Investigations and Corrective and Preventive Actions (CAPA).
Identify and implement improvement projects.
Author, review and approve technical, process and manufacturing documentation such as Batch Records and Standard Operating Procedures.
Support commissioning, qualification, validation, and technology transfer activities.
Work with cross-functional teams to manufacture materials for clinical and commercial projects.
All other duties as assigned