Process Engineer IV, MSAT

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

Brief Job Description

The MSAT Process Engineer IV has responsibility for execution of technical aspects of product and/or process 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 to manufacturing. 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 to commercial manufacturing follows project timelines and corporate standards.

Job Responsibilities

* Ensures there is single process in implementing and maintaining Electronic Batch Records (EBR) at the site.

* Leads all continuous process improvement efforts in the EBR work space for the MSAT technical team.

* 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 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, reviews, and approves documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms.

* Authors, reviews, and approves 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.

* 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 Requirements

* Experience in GMP or regulated production environment

* Training and/ or experience in Electronic Batch Record Deployment and maintenance

* Proficiency in more than one of the following disciplines: automation/ controls, aseptic/packaging equipment, process/materials, maintenance, validation

Preferred Background

* Bachelor's Degree in Engineering or computer science, or related science

* 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, validation

* Ability to coach and mentor peers

* Technical understanding of cGMPs and the global standards for EBRs

#LI-RM1

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.