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 visitPosition Summary & ResponsibilitiesPlans, leads, executes, and troubleshoots the qualification of facility, utility, process, and cleaning, equipment, and processes.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.Ensure proper documentation practices during job activities.Gather, organize, and communicate qualification information to others.Communicate priorities and progress to team on a continuing basis.Guide others on Validation SOPs (Standard Operating Procedures), control documents, and/or other work instructions.Initiate appropriate action when process deviations occur.Coordinate with representatives from other departments, including attendance of inter-departmental meetingsInteract with other departments to implement corrective/preventative actions.Participate in cross-functional teams to meet strategic goals.As a Validation SME, review and assess 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), SOPs (Standard Operating Procedures), and all required safety procedures.Read and interpret diagrams, drawings, and other schematics.Facilitate / coordinate the execution of validation protocols for pharmaceutical equipment and processesConsult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.Support process improvement activities and teams to meet strategic goals.Own and close Quality Records as neededInteract with regulatory agency personnel during audits and inspections.Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.Participate in new equipment design specification.Read technical publications and manuals and write associated procedures.Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.Occasionally Provide "off shift" support (for example: night shift support if you normally work day shift).Recommend compliance resolutions to management.Review and approve requirements, specifications, drawings, coding procedures, and guidelines.Minimum QualificationsExperience in validation or process engineering.Demonstrated experience in a manufacturing or processing settingAbility to expertly read and interpret drawings and diagramsStrong analytical skills, with keen attention to detailStrong communication skills, both written and verbalDemonstrated knowledge of health and safety guidelinesGood technical writing skillsGood problem-solving abilitiesAbility to prioritize own time and workloadPreferred QualificationsBachelor's degree in Engineering or a related technical disciplineExperience in a Pharmaceutical cGMP or other regulated environment.Strong knowledge of analytical methodology and instrumentationStrong knowledge of chemical process safety, validation, and quality assuranceResilience 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 identit