Sr. Automation Engineer
Job Summary
The Senior Automation Engineer works under the direction of the Senior Automation Manager while performing day-to-day project duties involving the design, development, and release of deliverables for biopharmaceutical manufacturing equipment. Key responsibilities include generating design plans, supporting operations, managing vendor and software support contracts, and collaborating with Quality and Validation teams.
Job Duties
Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment, utilities, and follow GAMP 5 and LSNE Data integrity guidelines.
Participate in Control System initiatives such as Change/Project Implementation, Incident/Issue Investigation & resolution, CAPA & Safety related corrective actions, and manufacturing support.
Support the operation of all GMP and non-GMP systems and other auxiliary equipment.
Assist manufacturing operations with problem-solving regarding automation systems.
Develop support models to assure robust operations.
Manage critical automation projects through the entire project life cycle and ensure systems are maintained in a validated state after going live.
Lead automation system documentation, prepare technical and user documentation, and conduct system training.
Lead system maintenance and manage automation life cycle (review application patching, document test plans, and execute test scripts).
Prepare RFQ’s and solicit quotations from automation suppliers.
Design the layout of equipment and workspace for maximum efficiency and safety.
Design and engineer moderate and complex automation equipment, tooling, and applications.
Develop budget, schedule for projects, and manage projects to stay within them.
Conduct equipment design reviews and provide design guidance to suppliers and status reports.
Provide on-site support during machine build, debug, and testing/qualification.
Supervise installation and testing to verify requirements and specifications are met.
Develop manufacturing solutions with the best combination of manual, semi-automation, and/or full automation.
Facilitate assembly processes through the implementation of assembly cells and automated equipment at NPI stage and ensure meeting development timeline.
Professional Skills
Able to prioritize and drive to results with a high emphasis on quality and to integrate and apply feedback in a professional manner.
Work both independently and in a team environment at all levels of the organization.
Experience
10+ years’ experience in a regulated environment (e.g., FDA).
Manufacturing engineering experience, working with automated manufacturing processes.
Experience coding/configuring in process controls (Control Studio, Batch, etc.).
Experience working with PLC and HMI applications (including RSlinx, RSlogix5, 500, 5000, & Factory Talk View).
Experience integrating/interfacing equipment to control systems via OPC, Ethernet IP, etc.
Experience with OSISoft Pi Historian and MES.
Control panel and automation hardware design experience.
Demonstrated knowledge of 21CFR Part 11, Annex 11, and GAMP5.
Education
A Bachelor of Science degree in Computer Science, Chemical, Electrical or Mechanical Engineering.