A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Position Summary & Responsibilities

This is a Blended Role: automation engineer, serialization, production/ process engineer, and related levels. Responsible for ensuring one technical process exists within the PET/Facility. This includes equipment, materials, processes, and procedures with applicable validation. Leads improvement initiatives as the technical expert and is the first line of support for all project-related work. Responsible for maintaining a strong relationship with Technical Operations and Quality areas and collaborating within the PET/Facility and with other PET Engineers. Serves as the single point of contact for all technical issues.

• Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.

• Interface with several types of equipment and systems, including but not limited to PLCs, SCADAs, HMIs, Servers, Databases, Data Historian, Visualization, Serializations systems, and other automation equipment/serialization processes.

• Experience with networking, including but not limited to VLAN, Subnets and IP protocols.

• Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for the improvement of automated pharmaceutical manufacturing equipment.

• Ensures success criteria for technology transfer and validation are clear and the process is capable for the merge into the PET/Facility process • Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/ reports

• Coordinate and support PET's/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence. Manages the life cycle of assets

• Maintain external technical relationships and collaborates with equipment and material suppliers

• Identify, develop, generate, and manage the implementation of appropriate change controls to improve processes and address root causes identified in investigations

• Perform and maintain risk management activities for new and existing processes/equipment • Initiate deviations and performs/facilitate the technical investigations and assessment of impacts

• Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures, and other forms. Author, review, and approve validation and change control documents such as master plans, protocols, summary reports, and change requests

• Provides input and develops user requirements for new asset procurement

• Provide engineering and project management services

• Assist in the development of project justification and engineering proposals including providing input for capital planning process

• Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment

• Perform routine validation and periodic reviews activities

• Works collaboratively within PET as well as with other PET Engineers and Technology Community such as Technology and Engineering, global colleagues

• Supports and leads technical trouble shooting

• On-call support as required

• Key contact for regulatory inspections as technical process owner

• Participates in annual product review process

• Participates in biennial critical systems review process

• Responsible for process validation required because of changes to validated processes within the PET.

Minimum Requirements:

• Expertise in at least one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation

• Experience with the following Automation systems; PLCs, HMIs, SCADA, Rockwell Inductive (Ignition) Aveva (Wonderware), Siemens, Emerson (GE) or B&R

• Experience with digital identification and traceability solutions, serialization systems such as Systech.

• Ability to interpret diagrams, drawing, PLC code and other schematics.

• Extensive experience in GMP or regulated production environment

• Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics

Preferred Requirements

• Minimum 4 years of experience in GMP or regulated production environment

• BS in Engineering, or related science

• Ability to develop proficiency in all the following disciplines: automation/ controls, serialization, packaging equipment, process/materials, maintenance, validation

• Ability to coach and mentor peers

• Experience with Factory Talk Batch

• Experience with Data Historian and Visualization systems such as Aveva PI (OSI PI)

• Experience with Microsoft SQL database design.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.