Senior Controls Engineer (Contract)

Vertex Pharmaceuticals•Boston, MA

16d•$75 - $90•Hybrid

About The Position

Are you ready to revolutionize Cell & Gene Therapy? Join us in shaping the future of therapeutics! We are seeking a Senior Controls Engineer in our journey of developing cutting-edge manufacturing solutions. In this role, you will be at the forefront of automating and digitizing complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. By leveraging your expertise in controls you will play a pivotal role in streamlining manufacturing, enhancing manufacturing reliability, and scaling life-saving therapies to reach patients faster. You will work with a passionate team of scientists, engineers, and innovators, all united by a shared mission: to push the boundaries of what’s possible in Cell & Gene Therapy. This role reports to the Associate Director of Automation, Equipment, and Processes.

Requirements

BS or MS in engineering or another relevant discipline.
10+ years of experience working within an electrical and controls environment (pharmaceutical, cGxP preferred). Experience with cell & gene therapy is highly desirable.
Experience working with Delta V, Allen Bradley, and Siemens.
Knowledge and practical experience of Equipment related laws, regulations, and standards.
Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products.
Experience troubleshooting industrial automation, including, but not limited to PLCs, camera systems, and sensors.
Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
Must demonstrate strong interpersonal, presentation, and teamwork skills.

Responsibilities

Design control and automation systems from benchtop to commercial across multiple therapeutic modalities. Perform tuning and troubleshooting of control loops, hardware, and software. This will include integrating multiple components and technologies, such as PLCS, relays, valves, MFCs, HMIs, actuators, robotics, and sensors.
Programming software, including, but not limited to Ladder Logic, Functional Block Diagram, Structured Text, Sequential Function Charts, and Instruction List. Programming environments include, but are not limited to Rs Logix, TIA Portal, Delta V Programming Environment, B&R Automation Studio, and various robotic programming environments.
Design equipment to interface with enterprise level systems, including, but not limited to, Oracle OPM, POMS MES, Ignition SCADA, OSI PI Historian, and Sepasoft Batch management.
Design and manage external design of electrical schematics, industrial control panels, and P&IDs.
Co-create Machine Safety Risk Assessments. Design equipment and engineering safeguards that meet applicable laws, regulations, and standards.
Support FAT, SAT, commissioning, and qualification activities.
Provide periodic status updates to Project Management and cross-functional partners.
Create phase plans for automation systems and contribute to an automation masterplan.
Create and oversee the creation of technical documentation, including, but not limited to URS, FRS, FMEAs, P&IDs, manuals, work instructions, and maintenance plans.
Execute assigned duties on time and within budget; proactively communicate delays and other issues to relevant stakeholders.
Comply with all regulatory, corporate, and Quality System policies. Support Deviation Management, CAPA, and Change Control activities, as required.
Performs other duties as assigned.