Specialist Engineering

MSD•Durham, NC

1d•$87,300 - $137,400

About The Position

The Specialist, Engineering is a member of the Technical Operations team supporting thawing, pooling, and filling manufacturing areas. The role collects and interprets information, develops solutions, and makes decisions for projects of varying scopes, with minimal supervision from the Associate Director and periodic reviews of technical judgment and project status. The Specialist 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. The position provides technical support for pharmaceutical manufacturing, quality and regulatory activities, process and equipment changes, and critical manufacturing runs. It also reviews pharmaceutical aseptic filling and lyophilization literature to identify opportunities to improve profitability and productivity. The role requires a bachelor’s degree in Engineering or a related field and at least two years of relevant industrial experience. The position is based in Durham, North Carolina, is a first-shift role, and requires 10% travel. Relocation is not offered, and visa sponsorship is not available.

Requirements

Bachelor of Science degree in Engineering or a related field.
At least two years of relevant industrial experience; the education section specifies two years’ 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 business projects, including 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 searching literature, designing and executing experiments, reviewing current and historical data, and demonstrating effects on product quality, production efficiency, or productivity.
Provide technical assistance 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, applying knowledge of Drug Product operations, hazards, and in-process controls.
Complete process engineering and process development activities in compliance with company and Durham site safety, quality, and regulatory requirements.
Review literature on pharmaceutical aseptic filling and lyophilization to identify profitable and productivity-enhancing ideas for Drug Product operations.
Provide technical support for equipment component design, machinability evaluation, process performance qualification, and qualification of new or modified equipment components.
Support critical manufacturing runs on shift, including Aseptic Process Simulation, protocol execution, and developmental runs.
Author process change controls and complete tasks to implement Drug Product equipment and process changes.