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Urgent! Validation Engineer II Job Opening In Indianapolis – Now Hiring Bristol Myers Squibb

Validation Engineer II



Job description

Working with Us
Challenging.

Meaningful.

Life-changing.

Those aren’t words that are usually associated with a job.

But working at Bristol Myers Squibb is anything but usual.

Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.

Take your career farther than you thought possible.

Summary

The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis.

The Validation Engineer II will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the use of highly specialized facility, utility, analytical, and process equipment.

The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations.

Additional responsibilities may include the onboarding of new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement projects, and future facility expansion projects.

Job Duties

Essential duties and responsibilities include the following.

Other duties may be assigned.

  • 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.

  • 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.

  • 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 validation support for day-to-day development and GMP operations

  • Provide engineering and operational support as required

  • Expand expertise in additional areas of validation (process validation, QC assets, CSV, cleaning validation, etc)

  • Own and manage a specific area of validation (i.e. process validation, QC assets, CSV, cleaning validation, etc)

  • Apply technical knowledge and abilities to investigate manufacturing deviations

  • 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.

  • Support Health Authority Inspections

  • Maintain department KPIs related to performance

  • Mentor and cross-train other team members

  • Execute and provide support executing equipment and process validations as necessary.

  • Education and Experience

  • BS or MS in scientific related field or equivalent work experience

  • 2-5 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment

  • 2-5 years of validation experience within a GMP environment

  • Skills and Qualifications

  • 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

  • Excellent professional ethics, integrity, and ability to maintain confidential information.

  • Physical Demands

    While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear.

    The employee must occasionally lift and/or move up to 30 pounds.

    Specific vision abilities required by this job include close vision and distance vision.

    This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.

    Work Environment

    The noise level in the work environment is usually moderate.

    #RayzeBio, GPS_2025, #LI-Onsite

    Compensation Overview:

    Indianapolis - RayzeBio - IN: $96,148 - $116,508

    Uniquely Interesting Work, Life-changing Careers
    With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary.

    Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol

    BMS has an occupancy structure that determines where an employee is required to conduct their work.

    This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

    The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

    Site-essential roles require 100% of shifts onsite at your assigned facility.

    Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

    For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

    For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

    Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

    If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to .

    Visit to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

    As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.


    Required Skill Profession

    Engineers



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      Unlock Your Validation Engineer Potential: Insight & Career Growth Guide


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