Validation Engineer, Sterility & CQV
- for any list of duties/requirements/benefits. Use
for prose. We must output only HTML fragment, no /, no markdown fences. Let's extract content. Summary paragraph: "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/" We can keep that as About the role. Responsibilities: The bullet list under "Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned." Then list items each starting with a verb. We need to capture each as
- . Let's list them:
- Work with the project team, General Contractor, consultants, and cross-functional partners as required to support commissioning, qualification, and validation activities for GMP and supporting spaces, including office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
- Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility assurance, and process systems.
- Support environmental monitoring programs, aseptic process simulations/media fills, airflow visualization smoke studies, cleanroom performance qualification, disinfection and sanitization validation, and VHP/bio-decontamination studies.
- Execute qualification activities for laboratory and analytical equipment, including HPLC/UPLC systems, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, and microbiology laboratory equipment.
- Provide validation support for day-to-day development, GMP manufacturing, laboratory, and operational activities, including troubleshooting, data review, investigation support, and validation impact assessments.
- Expand expertise in additional areas of validation, including process validation, QC assets, cleaning validation, sterility assurance, and analytical equipment qualification.
- Own and manage assigned validation areas or project workstreams while supporting validated state maintenance.
- Apply technical knowledge and abilities to investigate manufacturing, laboratory, sterility assurance, and validation-related deviations.
- Review data and documentation to support investigations, deviation closure, CAPA effectiveness, change control implementation, inspection readiness, and validated state maintenance.
- Draft GMP documentation including but not limited to SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, change controls, test scripts, and summary reports.
- Support Health Authority inspections, internal audits, and department KPI tracking related to validation performance, execution status, and compliance.
- Mentor and cross-train other team members.
That's the list.
Education And Experience: "BS or MS in scientific related field or equivalent work experience 2-5 years of experience in Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical laboratory, quality control, or GMP manufacturing environment 2-5 years of validation experience within a GMP environment Experience drafting, executing, or reviewing qualification and validation protocols is preferred"
We can treat as Requirements section.
Skills And Qualifications: list bullet points: "Good technical writing skill-set Solid understanding of regulatory guidelines for validation, lifecycle management, data integrity, documentation practices, and risk management Working knowledge of GMP requirements, CQV principles, sterility assurance, contamination control, environmental monitoring, analytical laboratory instrumentation, and risk-based validation methodologies Must possess an independent mindset, tenacity, sound judgment, and attention to detail Highly motivated and organized professional with strong interpersonal, communication, problem-solving, data analysis, and planning 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. Uses AI tools to enhance individual productivity and quality of work"
We can put as Skills section.
Physical Demands and Work Environment maybe not required sections; but we could include under About the role? Probably not needed; but we could include as part of About the role? The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. Physical Demands and Work Environment are specific content; but we don't have predefined headings for them. The allowed headings list includes About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we cannot add other headings. So we need to fit that content somewhere else, maybe within About the role or Responsibilities? But they are not duties. Could be part of About the role? Might be okay to include as a paragraph under About the role? However the instruction says "Prefer a few substantive sections over many thin ones." We could incorporate physical demands and work environment into About the role paragraph (maybe as additional sentences). But we must preserve ALL substantive information; we cannot drop it. So we need to include it somewhere. Could add a
under About the role after the summary, describing physical demands and work environment. That seems acceptable. Compensation Overview: includes pay range and details. We'll make Pay section. Benefits: we have a Benefits section with details. We'll include Benefits section. Schedule: not present, omit. Now we need to avoid boilerplate: remove lines like "If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway..." etc. Also remove "Learn more about RayzeBio: https://careers.bms.com/rayzebio/" maybe keep as part of About the role? It's a link; we can keep as part of summary. It's not boilerplate; it's substantive. Keep. Remove "Supporting People With Disabilities etc. That's EEO/legal boilerplate; remove. Remove "RayzeBio and Bristol Myers Squibb RayzeBio was acquired..." etc. That's boilerplate; remove. Remove "Supporting People With Disabilities BMS and RayzeBio are dedicated..." etc. Remove. Remove "Applicants can request a reasonable workplace accommodation..." etc. Remove. Remove "Visit careers.bms.com/eeo-accessibility..." etc. Remove. Remove "Candidate Rights ..." Remove. Remove "Data Protection ..." Remove. Remove "If you believe that the job posting is missing information required by local law..." Remove. Remove "Please provide the Job Title and Requisition number so we can review." Remove. Remove "Communications related to your application should not be sent to this email and you will not receive a response." Remove. Remove "R1605491 : Validation Engineer, Sterility & CQV" maybe drop as metadata; we can fold into short p or drop. Probably drop. Now construct HTML. We'll have:
About the role
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/ The role requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials. Physical demands include sitting, reaching with hands and arms, talking or hearing, and occasionally lifting/moving up to 30 pounds. Required vision abilities include close and distance vision. Work environment noise level is usually moderate.
Then Responsibilities:Responsibilities
- ... ...
Requirements
BS or MS in scientific related field or equivalent work experience; 2‑5 years of experience in Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical laboratory, quality control, or GMP manufacturing environment; 2‑5 years of validation experience within a GMP environment; experience drafting, executing, or reviewing qualification and validation protocols is preferred.
Then Skills:Skills
- Good technical writing skill‑set
- Solid understanding of regulatory guidelines for validation, lifecycle management, data integrity, documentation practices, and risk management
- Working knowledge of GMP requirements, CQV principles, sterility assurance, contamination control, environmental monitoring, analytical laboratory instrumentation, and risk‑based validation methodologies
- Must possess an independent mindset, tenacity, sound judgment, and attention to detail
- Highly motivated and organized professional with strong interpersonal, communication, problem‑solving, data analysis, and planning 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
- Uses AI tools to enhance individual productivity and quality of work
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