Project Engineer III
Discovery Drive, SWDD Swiftwater, PA
The Equipment Engineer executes process design engineering activities for site capital and operational improvement projects within the Technical Engineering team in Swiftwater with a primary focus in the aseptic fill/finish area. In support of capital projects, the Equipment Engineer will participate in the development of concepts and specifications, design and fabrication, commissioning and qualification of process equipment systems in a GMP environment. The Equipment Engineer will also support licensed GMP operations by providing technical leadership for investigations/assessments, and by developing and implementing improvement projects.
This Equipment Engineer will lead or participate in the development of URS’ s, equipment, instrument, and component specifications, engineering calculations, computational fluid dynamics simulations, engineering design including PFD and P&ID development, FAT and SAT planning/execution, initial start-up, commissioning and qualification of process systems.
The Equipment Engineer will also be a hands-on, process and equipment oriented, technical leader for the aseptic filling area. This includes providing engineering support for the operation, control, and maintenance of all aseptic fill/finish equipment including vial washers, depyrogenation tunnels, aseptic fillers, lyophilizers, capping equipment, trayloaders, denester/renesters, visual inspection equipment, autoclaves, RABS and Isolators.
The incumbent is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments.
- Develop technically sound concepts and scope for aseptic fill/finish capital and improvement projects
- Specify and design equipment
- Manage equipment vendors to meet requirements as well as project cost and schedule
- Develop and execute C&Q deliverables
- Identify changes to improve processes and address root causes identified in investigations in a cGMP environment.
- Develop and implement improvements through cross-functional interactions.
- Interface with Industrial Operations to ensure the manufacturing process equipment operates in its validated state and consistently meets the production schedule. Continuous improvement is required.
- Provide Subject Matter Expert (SME) knowledge as required on equipment within area of responsibility.
- Closely interact with Industrial Operations to develop, implement, and improve operations and maintenance practices and procedures.
- BS in chemical or mechanical engineering, or related degree supplemented with relevant experience. Experience in pharmaceutical/biopharmaceutical industry.
- Experience in cGMP environment, including commissioning, qualification and validation.
- Well-developed communication skills, both verbal and written.
- Based on level, should have demonstrated experience managing teams consisting of internal staff, supervising engineering and construction activities, and preparing turnover documentation from C execution and as-built drawings.
- Based on level, demonstrated project controls skills such as estimating, scheduling and cost reporting. Larger projects may require earned value/progress tracking systems.
- Leadership skills. Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.)
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.