Engineer Senior, Biotech Manufacturing and Process Equipment (JP12842)

$64,002 - $123,656/Yr

Unclassified - West Greenwich, RI

Full-time - Mid Level

West Greenwich, RI

About the position

The Engineer Senior, Biotech Manufacturing and Process Equipment position is a critical role within a leading global biotechnology company located in West Greenwich, RI. This position is fully onsite and is expected to support manufacturing activities associated with process equipment at the facility. The engineer will collaborate closely with maintenance teams, project management, and engineering technical leads to enhance the operation and reliability of manufacturing equipment. The role involves identifying and implementing engineering-based improvements or upgrades to equipment systems, which includes developing justifications for improvements, identifying design requirements, and translating these into process equipment/system designs. The engineer will also support the construction, startup, and validation of equipment, ensuring that all activities align with safety and regulatory standards. In addition to technical support, the engineer will play a key role in Lean Transformation initiatives aimed at improving operational efficiency. This includes documenting improvement opportunities that reduce costs, enhance safety and quality, and increase speed. The engineer will be accountable for verification deliverables on key capital projects and will coordinate equipment maintenance to ensure systems are functioning optimally. They will also oversee verification deliverables developed by outsourced verification staff and develop commissioning and function test plans for equipment modifications. The position requires the engineer to monitor systems for performance risks and implement strategies to mitigate these risks. They will provide problem-solving support to minimize production downtime, which may involve leading technical root cause analyses with multidisciplinary teams. The engineer will also support new product and technology introductions by conducting engineering assessments and implementing necessary equipment modifications. Safety is paramount, and the engineer must ensure that all systems are installed and operated in compliance with environmental health and safety regulations. The role also includes providing ad hoc technical support and guidance to manufacturing and maintenance teams, coaching project teams on risk-based approaches to commissioning and verification, and assisting in the development and maintenance of operational metrics. Flexibility in work hours is required to support 24/7 operations, including occasional after-hours coverage.

Responsibilities

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment systems.
• Develop reasons for improvement and identify design requirements, translating them into process equipment/system design.
• Support Lean Transformation and Excellence in Operations process improvement initiatives.
• Be accountable for verification deliverables on key capital projects.
• Advise and coordinate equipment maintenance to ensure systems are operational.
• Provide oversight for verification deliverables developed by outsourced verification staff.
• Develop commissioning and function test plans for equipment modifications and acquisitions.
• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
• Support Manufacturing and QA with Performance Qualification (PQ) activities.
• Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Provide problem-solving support to reduce production downtime.
• Support new product/technology introductions by performing engineering assessments and implementing equipment modifications.
• Ensure systems are installed and operating safely in compliance with environmental health/safety practices.
• Provide ad hoc technical support and guidance for manufacturing and maintenance.
• Coach project teams and engineers on the CQP process and risk-based approaches to commissioning and verification.
• Assist in developing and maintaining metrics.

Requirements

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.
• 4 to 6 years of engineering and technical background on process equipment in the pharmaceutical industry.
• Local to West Greenwich, Rhode Island.
• No work gap more than 3 months.
• Demonstrated ability to work independently with minimal supervision.
• Motivated to take on new challenges.
• Detail-oriented and data-driven problem-solving skills.
• Experience in cross-functional collaboration with multidisciplinary functions.

Nice-to-haves

• Bachelor's degree in chemical or other engineering fields.
• 6+ years of relevant work experience with 5+ years in a biopharmaceutical operations/manufacturing environment.
• Experience in a regulated environment (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes.
• Direct knowledge of design and troubleshooting with GMP biopharmaceutical production facility equipment/systems.

Benefits

• Competitive hourly rate between $44.00 and $48.00.
• Contract duration of 1+ years with possible extensions.
• Opportunity for up to 20% domestic travel for cross-site training.