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

Position Summary & Responsibilities

The MSAT Process Engineer IV leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. The position 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. This engineer will focus on Visual Inspection (automated and manual) within the MSAT team.

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

* Focused on and owns the responsibilities within the MSAT team related to visual inspection (automated and manual) of filled container closures

* Seen as the Visual Inspection SME within the MSAT team and the site

* Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated inspection 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 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.

* Owns and develops user requirements for new asset procurement.

* Provide engineering and project management services.

* Lead 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 Qualifications

* Significant experience supporting manufacturing operations in a regulated or cGMP environment

* Expertise in one or more of 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

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

* Experience in leading a team to install and qualify new equipment to achieve site strategic priorities

* Experience in identifying, justifying, implementing, and testing process improvements within a cGMP regulated environment

* Experience in being the subject matter expert (SME) in a given field or process

Preferred Qualifications

* Bachelor's Degree in Engineering, or related science

* Visual inspection experience (automated and/or manual)

* Vision systems experience

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

* Ability to coach and mentor peers

* Experience in quality management systems to address deviations, create/implement change controls, and implement corrective/preventive actions (CAPAs)

This position may also include the following conditions:
Specific visual skills (i.e., extensive reading or computer use, normal color vision, depth perception, or visual acuity)

Specific hearing requirements - Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents.

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.