Sr. Automation Engineer

PCI Pharma Services•Bedford, NH

About The Position

The Senior Automation Engineer works under the direction of the Senior Automation Manager while also utilizing independent judgment to perform the day-to-day project duties of designing, developing and releasing deliverables used in the fabrication of equipment for pilot and commercial scale biopharmaceutical manufacturing (Primarily piping assemblies for fluid & gas handling and motorized agitation systems). Primary responsibility involves generating design plans. The Senior Automation Engineer will play a key role of work ownership and accountability for LSNE automation systems. The incumbent will develop support models to assure robust operations, manage vendor and software support contracts, and work closely with the Quality and Validation teams to ensure these systems are ready for use. The incumbent is to be the expert in a variety of automation systems, have a love of learning, and not be afraid to get into the details and execute to solve problems. The Sr. Automation Engineer possess expertise in engineering, design, installation and start-up of automation systems. They will assist manufacturing operations with problem solving regarding automation systems. May also develop code and design system architectures to define user compatibility.

Requirements

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 with FactoryTalk software and applications.
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.

Nice To Haves

Able to prioritize and drive to results with a high emphasis on quality and to integrate and apply feedback in a professional manner.
Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production.
Work both independently and in a team environment at all levels of the organization.

Responsibilities

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 with Programmable Logic Controllers (PLC’s).
Take leadership during the entire life cycle of automation projects, from concept to feasibility and from fabrication and test to production.
Design and document new test methods to measure equipment performance.
Manage critical automation projects through the entire project life cycle and ensure systems are maintained in a validated state after going live.
Work hand in hand with Facilities, Engineering, and Operations teams to support projects and operational needs.
Develop and manage design standards for our automation platforms.
Implement, maintain, and optimize automated platforms for the commercial and research laboratories.
Provide configuration, development, and break/fix day-to-day support of automation systems.
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.
Evaluate supplier quotations to determine the best combination of technical solution, cost and timing.
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.
Support new product development automation needs, facilitate assembly processes through the implementation of assembly cells and automated equipment at NPI stage and ensure meeting development timeline.