Validation Engineer 1

Bristol Myers Squibb • Indianapolis, IN

8d • $82,236 - $99,650 • Onsite

About The Position

The Validation Engineer I supports the Radiopharmaceutical facility and GMP operations in Indianapolis. This role assists with the drafting and execution of commissioning, qualification, and validation (CQV) documents and protocols that support specialized facility, utility, analytical, and process equipment. Working under the guidance of senior team members, the Validation Engineer I contributes to validation activities that support the transition from construction to clinical development and ongoing GMP commercial operations. Additional responsibilities may include supporting new technology onboarding, process development, deviation investigations, CAPA activities, continuous improvement initiatives, and facility expansion projects.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related scientific field, or equivalent work experience.
• 0-2 years of experience in a GMP manufacturing environment, preferably in radiopharmaceutical or injectable manufacturing.
• Basic technical writing skills.
• Foundational understanding of validation principles, GMP requirements, and risk management concepts.
• Strong attention to detail, organization, and willingness to learn.
• Effective interpersonal and communication skills.
• Ability to work collaboratively in a cross-functional GMP environment.
• Demonstrated professionalism, integrity, and ability to handle confidential information appropriately.
• Problem-solving mindset with the ability to follow direction and grow into increased technical ownership.
• Use AI tools to enhance individual productivity and quality of work

Nice To Haves

• Exposure to validation, commissioning, qualification, or related technical support activities is preferred.

Responsibilities

• Support the project team and/or General Contractor, as needed, in commissioning and validation activities for GMP and supporting spaces.
• Assist in the development and implementation of CQV strategies for office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Partner with consultants and cross-functional teams to support the implementation and execution of the CQV program.
• Provide validation support for day-to-day development and GMP operations.
• Execute or support equipment, utility, and process qualification activities as required.
• Assist with drafting GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, and change controls.
• Review data and documentation to support investigations and validation packages.
• Contribute to continuous improvement projects and assigned validation initiatives.
• Build knowledge in additional areas of validation such as process validation, QC assets, computer system validation, and cleaning validation.
• Support department KPI tracking and inspection readiness activities.
• Provide engineering and operational support as needed.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and RayzeBio Exempt, Non-Exempt, Hourly Employees: 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.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level