Validation Engineer III

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

* Author, Review and approve documentation needed for qualification of equipment and
processes.
* Prepare documentation of activities, actions, and/or results.
* Monitor records to ensure compliance with regulatory requirements.
* Complete required training.
* Answer compliance and process questions from others.
* Coordinate with representatives from other departments.
* Interact with other departments to ensure that product is inspected under validated conditions

* Interact with other departments to implement corrective/preventative actions.
* Participate in cross-functional teams to meet strategic goals.
* Review and approve deviations, change controls, and document revisions.
* Attend team meetings to discuss progress, initiatives, and/or other matters.
* Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs and so on.

* Read and interpret diagrams, drawings, and other schematics.
* Facilitate the execution of validation protocols for processes, equipment, packaging, and/orcleaning.
* Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processeswithin a functional area.
* Coordinate qualification activities.
* Participate in troubleshooting activities.
* Facilitate communication between management and non-management.
* Close out deviations, CAPAs, and/or change actions as needed.
* Interact with regulatory agency personnel during audits and inspections.

* Recommend and initiate activities to ensure area and equipment is maintained in a state ofcompliance.
* Occasionally Provide "off shift" support (for example: night shift support if you normally work day shift).
* Assist process engineering and managers with improvement projects.

* Recommend and initiate activities to ensure area and equipment is maintained in a state ofcompliance.

* Occasional Off shift support

Minimum Qualifications
* Experience in validation or process engineering.
* Demonstrated experience in a manufacturing or processing setting
* Ability to expertly read and interpret drawings and diagrams
* Strong analytical skills, with keen attention to detail
* Strong communication skills, both written and verbal
* Demonstrated knowledge of health and safety guidelines
* Good report writing skills
* Good problem-solving abilities
* Ability to prioritize own time and workload

Preferred Qualifications

* Bachelor's degree in engineering, Computer Science, or a related discipline

Experience in a regulated or cGMP environment.
* Strong knowledge of analytical methodology and instrumentation
* Strong knowledge of chemical process safety, validation, and quality assurance

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.