Lead Validation Engineer
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to these headings. The posting includes a "Summary" paragraph before responsibilities. That could be "About the role". We'll put that in About the role
with
containing that summary text. Then Responsibilities: list of duties. We'll put
Responsibilities
with- each duty.
Then Requirements: maybe education and experience? The posting has "Education And Experience". That could be Requirements. We'll put
Requirements
withfor prose? Actually it's a list: BS or MS..., 5+ years..., etc. Could be
- . We'll treat as list.
Then Qualifications: maybe "Skills And Qualifications". That could be Qualifications or Skills. The instruction includes both Qualifications and Skills headings. We have "Skills And Qualifications". We could split: Qualifications heading for the list of qualifications (maybe same as Skills). But we need to avoid duplication. Perhaps we put Qualifications for the bullet list of skills/qualifications, and Skills heading maybe not needed if content overlaps. But we should include only when posting has real specific content. The posting has "Skills And Qualifications" with bullet list. We could map that to
- .
Now Requirements: Education And Experience:
- BS or MS in a scientific or engineering discipline, or equivalent work experience.
- 5+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.
- 5+ years of validation experience within a GMP-regulated environment.
- Demonstrated experience leading complex validation programs and cross-functional initiatives.
- Prior experience mentoring engineers or leading project workstreams is strongly preferred.
We'll put as
- .
Now Skills And Qualifications list:
- Strong technical writing and document review skills.
- Deep understanding of regulatory expectations for validation, lifecycle management, and risk management.
- Strong leadership, decision-making, and problem-solving skills.
- Ability to work independently while effectively influencing cross-functional teams.
- Excellent communication, organization, and project management capabilities.
- Proven ability to prioritize multiple initiatives in a fast-paced GMP environment.
- Broad validation knowledge across areas such as process validation, cleaning validation, computer system validation, equipment qualification, and QC assets.
- High level of professional ethics, integrity, and ability to maintain confidential information.
- Applies AI to improve team execution and decision‑making
We'll put as
- under Skills.
Now Physical Demands and Work Environment: we need to preserve. We'll add a
under Requirements after the list, or maybe under Skills. Let's add a
under Requirements after the list: "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 position requires working in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials. Work Environment: The noise level in the work environment is usually moderate." Now Benefits: we need to include the benefits list. The posting includes a long benefits description. We'll capture the substantive benefit offerings: 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. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. We
Skills
(or Qualifications). Since both headings allowed, we need to decide. Probably better to useSkills
for that list, and maybe omit Qualifications if content same. But we also have Education And Experience which could be Requirements. So we will have sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay. Check if any other sections: maybe "Physical Demands" and "Work Environment". Not in allowed headings list, but we could incorporate into Requirements or maybe omit? The instruction says use headings from list; we should not create other headings. So we need to fold that content into existing sections, maybe under Requirements or Skills? But we must preserve ALL substantive information. We can't drop it. We could add aunder Requirements for Physical Demands and Work Environment. Or maybe create a separate section not in list? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "use
for section headings (e.g. ...)" implying we should use those headings for sections. It might be okay to add other headings if needed, but better to stick to given list. We can incorporate Physical Demands and Work Environment into Requirements or maybe a separate "Working Conditions" but not in list. Safer to add a
under Requirements after the list. Also there is "Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned." We'll capture duties after that. We need to remove duplicated lines, boilerplate like "Learn more about RayzeBio: https://careers.bms.com/rayzebio/" maybe that's part of About the role? It's a link; we could keep as part of summary? It's a link; we could keep as plain text? Probably keep as part of About the role paragraph. Also remove "undefinedundefined". Also remove "Compensation Overview" heading? We'll make Pay section. Also remove "Benefits" heading? We'll make Benefits section. Also remove "Supporting People With Disabilities", "Candidate Rights", "Data Protection", etc. Those are boilerplate EEO/legal; must remove. Also remove "RayzeBio and Bristol Myers Squibb RayzeBio was acquired..." etc. That's boilerplate about company; maybe part of About the role? It's not essential to role; but it's substantive? It's about company background. Might be considered boilerplate but it's describing the company. The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. This is not exactly those, but it's company description. Might be okay to keep in About the role? The initial paragraph already covers mission. The later paragraph about acquisition could be considered extra but not required. However we must preserve ALL substantive information; is that substantive? It's about the company, not the role. Might be considered boilerplate but not explicitly listed to remove. Safer to keep it in About the role? But it's lengthy. Could include as part of About the role paragraph. But we need to avoid duplication. The initial paragraph already mentions RayzeBio as subsidiary of BMS. The later paragraph repeats that. Might be duplicate; we can remove duplicate. We'll craft About the role paragraph summarizing: At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. 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. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ That seems good. Now Responsibilities: list each duty from "Lead cross-functional validation activities..." etc. We'll extract each sentence that starts with a verb. We'll need to ensure we capture all. Let's list responsibilities from the text: - Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs. - Develop, implement, and continuously improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces including office, warehouse, development, quality control, sterility/microbiology, and production areas. - Partner with project teams, consultants, contractors, Quality, Engineering, QC, and Operations to deliver validation milestones aligned with business and compliance objectives. - Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments. - Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation. - Review and approve validation documents including SOPs, forms, protocols, technical reports, deviations, CAPAs, change controls, and summary reports. - Lead deviation investigations and support root cause analysis, corrective actions, and preventive actions related to validation and manufacturing systems. - Drive continuous improvement projects that enhance compliance, efficiency, and operational readiness. - Mentor, coach, and develop validation engineers and cross-functional team members. - Support regulatory inspections and internal audits by presenting validation strategies, rationale, and supporting documentation. - Track and communicate departmental KPIs, project status, risks, and resource needs to leadership. - Support onboarding of new technologies, facility modifications, and expansion projects as required. We'll put each as
- .
Now Requirements: Education And Experience:
- BS or MS in a scientific or engineering discipline, or equivalent work experience.
- 5+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.
- 5+ years of validation experience within a GMP-regulated environment.
- Demonstrated experience leading complex validation programs and cross-functional initiatives.
- Prior experience mentoring engineers or leading project workstreams is strongly preferred.
We'll put as