Specialist Engineering

MSD•Durham, NC

3d•Onsite

About The Position

The Specialist, Engineering is a member of the Technical Operations team supporting thaw, pool, and filling manufacturing areas. The role collects and interprets information, develops solutions, and makes decisions on projects of varying scopes with very minimal supervision. The Associate Director provides guidance and conducts periodic reviews of technical judgment and project status and schedule. The position collaborates with Operations, Quality, and other support groups within an Integrated Product Team to meet manufacturing and compliance initiatives and execute continuous improvement and strategic production projects. It provides technical support to manufacturing operations, leads equipment-related root cause investigations, and develops scientific justifications for proposed changes through literature review, experimentation, and data analysis. The role also supports quality and regulatory activities, including inspections and technical documents for NDA supplements, and maintains accurate process descriptions and critical process parameter memoranda. The Specialist completes process engineering and development work in compliance with company and site safety, quality, and regulatory procedures. It reviews pharmaceutical aseptic filling and lyophilization literature, supports equipment design and qualification, provides on-shift assistance during critical manufacturing activities, and authors and implements process change controls.

Requirements

Bachelor of Science degree in Engineering or a related field.
At least two years of relevant industrial experience.
Experience in pharmaceutical operations, technical services, or quality operations.
Experience working in a GMP pharmaceutical environment.
Demonstrated leadership and teamwork skills.
Strong oral and written communication skills.
Mechanical aptitude to troubleshoot and resolve equipment issues.

Nice To Haves

Experience in deviation management, change control, equipment support, or project support.
Experience in the pharmaceutical industry.
Project management skills.
Experience writing process change controls.
Experience using Lean Six Sigma tools.

Responsibilities

Collaborate with Operations, Quality, and other support groups to meet manufacturing and compliance initiatives within an Integrated Product Team.
Execute and support continuous improvement changes and strategic production initiatives.
Provide technical assistance to manufacturing operations to resolve thawing, pooling, and filling equipment problems for in-line products.
Lead root cause analysis investigations for equipment-related quality events.
Develop written scientific justifications for proposed changes by conducting literature searches, designing and executing experiments, reviewing current and historical data, and demonstrating impacts on product quality, production efficiency, or productivity.
Provide technical support for quality and regulatory activities, including site inspections, technical documents for NDA supplements, FDA observations, and environmental process issues.
Maintain the accuracy of Process Descriptions and Critical Process Parameter Memos.
Complete process engineering and process development activities in compliance with company and Durham site safety, quality, and regulatory procedures.
Review literature on pharmaceutical aseptic filling and lyophilization to identify ideas that could improve profitability or productivity in Drug Product operations.
Provide technical support for equipment component design, machinability evaluation, process performance qualification, and qualification of new or modified equipment components.
Provide on-shift support during critical manufacturing runs, including Aseptic Process Simulation, protocol execution, and developmental runs.
Author process change controls and complete tasks to implement Drug Product equipment and process changes.