Senior Controls Engineer (Contract)

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 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 whats possible in Cell & Gene Therapy. This role reports to the Associate Director of Automation Equipment and Processes.

Key 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.

Required Qualifications:

• 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.
• This is a 5 days a week role requiring 3 days on-site per week at our Boston and Providence offices.

Contract Length: 6 month with the chance to extend.

$75/hr. - $90/hr.

Monday - Friday

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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