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

The MSAT Process Engineer II has responsibility for execution of technical aspects of product and/orprocess technology transfer to the site through successful completion of PPQ. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process tomanufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations,Quality, and technical experts performing transfers to the site to ensure process implementation tocommercial manufacturing follows project timelines and corporate standards.

Position Responsibilities

• Ensures there is technical process with centerlines, critical process parameters, material fit foruse, and operating procedures are clear and delivers a capable process.
• Leads the following continuous process improvement efforts: changeover reduction, yieldimprovements, 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 Manufacturing/Facility process.
• Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/ reports.
• Coordinate and support Manufacturing/Facility improvement initiatives that define equipmentdata, equipment capabilities, utilization, efficiencies, and obsolescence. Manages life cycle ofassets.
• Maintain external technical relationships and collaborates with equipment and material suppliers. * Identify, develop, generate, and manage implementation of appropriate change controls toimprove processes and address root causes identified in investigations.
• Perform and maintain risk management activities for new and existing processes / equipment.
• Initiates deviations and performs/facilitates the technical investigations and assessment ofimpacts.
• Authors and reviews documents including Standard Operating Procedures, Batch Records,
  Rework procedures and other forms.
• Authors and reviews 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.
• Provides 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.
• Performs routine validation and periodic reviews activities.
• 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
  Manufacturing.

Minimum Qualifications

• Experience in GMP or regulated production environment
• Training or experience in some of the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI,Historian/reporting, computerized systems, vision systems, refrigeration, test equipment forelectrical and mechanical trouble shooting, aseptic/controlled environment, unit operations,formulation, packaging, process validation, cleaning validation, technology transfer, changecontrol, applied statistics
• Proficiency in at least one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation

Preferred Qualifications

• Bachelor's degree in engineering, or related science degree
• Project management
• Uses their insight to challenge and adapt current approaches/ways of doing things
• Experience in Six Sigma/ analytical trouble shooting skills
• Experience working in a LEAN manufacturing environment
• Expertise in more than one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation
• Ability to coach and mentor peers

This position may also include the following conditions:
The following is a checklist of a number of the principal physical and mental requirements of a positionwith Resilience. This document is intended to accompany, and should be read in conjunction with, the job description for the position. This is not intended as an exclusive list of essential functions for the position. Certain general requirements and functions - such as regular and predictable attendance atwork and working cooperatively with co-workers - apply to all positions at Resilience and are notspecifically listed here.

Physical and Mental Requirements
Lifting/Carrying 20 lbs.
Working at Heights of 5 ft.
Sitting
Standing
Walking
Bending
Stooping
Twisting
Reaching
Repetitive Motion
Noise Exposure
Operative Moving Machinery
Chemical Usage
Traveling
Wearing Personal Protective Equipment
Please describe the above and/or any other physical or mental requirements:
See job description.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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.