Job Description

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the process equipment. This may include development of rationale 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.
• Be individually accountable for the verification deliverables.
• Assist in the identification of critical quality parameters and process attributes for new equipment.
• 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.
• Assist in development and review of User Requirements Specifications (URS).
• Suggest design modifications to address risks and design in quality and safety.
• Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, SOPs, and standards.
• Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.
• Ensure safety during commissioning, validation, maintenance and manufacturing activities.
• 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.
• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
• Identifying reliability improvements for assigned equipment to improve equipment uptime.
• 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.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
• Provide concise and clear documentation for actions taken on systems.

• Engineering and technical background (process equipment, troubleshooting, data driven tech skills)
• Ideally would have 2 - 5 years pharmaceutical industry background. Bachelor degree Engineering
• Team work experience

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the process equipment. This may include development of rationale 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.
• Be individually accountable for the verification deliverables.
• Assist in the identification of critical quality parameters and process attributes for new equipment.
• 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.
• Assist in development and review of User Requirements Specifications (URS).
• Suggest design modifications to address risks and design in quality and safety.
• Develop or oversee development of commissioning and function test plan for any equipment modifications and acquisition in line with CQP, Automation Systems, SOPs, and standards.
• Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.
• Ensure safety during commissioning, validation, maintenance and manufacturing activities.
• 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.
• Ensure systems are installed and operating safely align with pertinent environmental health/safety practice, rules and regulations.
• Lead and provide ad hoc technical support and guidance in a timely manner for manufacturing and maintenance on equipment troubleshooting.
• Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
• Identifying reliability improvements for assigned equipment to improve equipment uptime.
• 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.
• Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time.
• Provide concise and clear documentation for actions taken on systems.

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Basic technical report writing and presentations
• Verbal communication
• Personal Organization
• Dealing with and managing change
• Technical (Equipment Specific)
• Analytical Problem Solving
• Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
• Specialized equipment/process expertise
• Ability to handle multiple projects/troubleshooting at the same time
• Schedule development, facilitation and collaboration
• Basic project management, project completion and follow-up
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Project Cost development
• Conflict Resolution
• Customer service in a technical setting
• Management of contractors and vendors.
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

• Bachelor's degree in engineering-related field
• 5+ years of relevant work experience with 3+ years’ experience in operations/manufacturing

• environment

• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on

• pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment

• 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.

• Process automation knowledge – understanding of automation infrastructure, current technologies,

• and automation project execution / verification.

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