Bristol Myers Squibb

Senior Validation Engineer

Indianapolis - RayzeBio - IN · Senior · Part-time

Sponsorship not specified$108k-$131kDetected 13 hours ago

AccessibilityExcelGMPCommunicationCollaborationWriting

About the role

Develop and implement the CQV strategies for the GMP spaces including but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
Provide validation support for day-to-day development and GMP operations
Own and manage a specific area of validation (i.e. process validation, QC assets, CSV, cleaning validation, etc)
Review data and documentation to support investigations
Own and drive projects and continuous improvement efforts
Draft GMP documentation including but not limited to SOP's, Forms, Protocols, Technical Documents, Reports, Deviations, CAPAs, Change Controls and reports.
Maintain department KPIs related to performance

The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience.
Work with the project team and/or General Contractor as required to support the commissioning and validation of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility.
Work with consultant(s) as required to support the implementation and execution of the CQV program.
Support the engineering, QC, and Operations team as required to improve and implement new processes
Provide engineering and operational support as required

Good technical writing skill-set
Solid understanding of regulatory guidelines for validation and risk management
Must possess an independent mindset and tenacity
Highly motivated and organized professional with strong interpersonal and communication skills.
Proven experience working with teams in a GMP environment.
Multi disciplined engineer with GMP experience
Uses AI tools to enhance individual productivity and quality of work

160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.
Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

This listing is sourced directly from Bristol Myers Squibb's careers page and normalized into a canonical job model.