Engineer Senior, Biotech Manufacturing and Process Equipment (JP12842)

• Notes: Fully onsite.  Up to 20% domestic travel for cross site training

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment systems.
• This may include development of reason for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality or improve speed.

• Be individually accountable for the verification deliverables on key capital projects.
• Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Develop commissioning and function test plan for any equipment modifications and acquisition.
• Ensure safety during commissioning, validation, maintenance and manufacturing activities.

• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable. 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.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.

• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications and supporting engineering runs.

• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Provide ad hoc technical support and guidance for manufacturing and maintenance.
• Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification.
• Assist in developing and maintaining metrics.
• Full time onsite support in required.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time

• 4 to 6 years Engineering and technical background on process equipment in pharmaceutical industry
• Local to West Greenwich, Rhode Island
• No work gap more than 3 months
• Demonstrated ability to work independently with minimal supervision
• Demonstrated to be motivated to take on new challenges
• Demonstrated ability to solve complex problems by being detail oriented and data driven
• Has shown cross functional collaboration with multidiscipline functions such as process development, engineering, automation, maintenance and management

• Identify, support, and/or lead implementation of engineering-based improvements or

• upgrades to the equipment systems. This may include development of reason for
• improvement and identification of design requirements and then translation of requirements
• into process equipment/system design, specification and supporting the construction,
• startup, and validation of equipment.
• Support Lean Transformation and Excellence in Operations process improvement by
• leading, supporting, and documenting improvement opportunities to reduce cost, improve
• safety/quality or improve speed.
• Be individually accountable for the verification deliverables on key capital projects.
• Advising and coordinating equipment maintenance as vital to ensure systems are in proper working order.
• Provide oversight for verification deliverables developed by outsourced/contract verification staff.
• Develop commissioning and function test plan for any equipment modifications and acquisition.
• Ensure safety during commissioning, validation, maintenance and manufacturing activities.
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
• 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.
• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis involving multidisciplinary site teams and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments,
• implementing equipment modifications and supporting engineering runs.
• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Provide ad hoc technical support and guidance for manufacturing and maintenance.
• Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification.
• Assist in developing and maintaining metrics.
• Up to 20% domestic travel for cross site training
• Full-time onsite support in required.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time

• Bachelor’s degree in chemical or other Engineering fields
• 6 years' relevant work experience with 5 years' experience in Biopharmaceutical

• operations/manufacturing environment
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and
• familiarity with GMP quality systems/processes such as change control, nonconformances,
• corrective and preventative actions, and qualifications/validation.
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production
• facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific
• manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process of capital projects in a GMP and/or non-GMP
• Biopharmaceutical Production facility including procurement, construction, startup, and
• validation
• Understanding of safety requirements working in a Biopharmaceutical Production facility.
• Independent, self-motivated, organized, able to multi-task in project environments, and
• skilled in communication, facilitation, and collaboration
• Phenomenal teammate prepared to work in and adopt a team based culture that relies on collaboration for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills

• No work experience
• No engineering or technical experience
• No collaboration experience
• No work gap of more than 3 months

Salary : $44 - $48