Process Engineer II

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. 

For more information, please visit www.resilience.com

Position Summary & Responsibilities

Responsible for ensuring one technical process exists within the PET/Facility. This includes equipment, materials, process, and procedures with applicable validation. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work.  Responsible for maintaining a strong relationship with Technical Operations and Quality areas, as well as, 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

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

• Ensures success criteria for technology transfer and validation is 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 life cycle of assets.

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

• Identify, develop, generate and manage 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/facilitates 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 as a result of changes to validated processes within the PET.

Minimum Qualifications
1. 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 
2. Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation 


Preferred Qualifications
1. BS in Engineering, or related science 
2. Strong verbal and written communication skills
3. Proven ability to work effectively in a team environment
4. Experience managing external technical relationships

5. Strong mechanical/technical aptitude
 

Resilience is an Equal Emp