Senior Specialist, Validation Engineer II

We need to output HTML fragment with sections: About the role? The posting includes description, duties, responsibilities, qualifications, compensation, benefits, ways of working, etc. We must not repeat job title as heading. Use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include sections only if posting has real specific content. We have compensation details: pay range $92,540 - $112,136. Benefits described. Schedule? Not explicit schedule; maybe not include Schedule section unless present. We have "How We Work" describing work models; could be considered "Work Model" but not in allowed headings; we could put under "About the role" maybe. We must not invent sections like "How We Work" unless we map to allowed headings. Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can use "About the role" for overview/purpose. "Responsibilities" for duties. "Requirements" maybe for qualifications? But we also have "Qualifications" heading allowed. Could separate "Qualifications" for education/experience, and "Skills" for knowledge/skill. "Benefits" and "Pay". No schedule info, so omit Schedule. We must preserve all substantive info, not invent or summarize away detail. Must not include boilerplate like EEO, legal, application instructions, etc. Remove duplicated lines. We need to extract substantive content: - About the role: purpose-driven culture, question, etc. Also description: "Job Description PRINCIPAL OBJECTIVE OF THE POSITION: The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization." We can put that in About the role. - Responsibilities: list of duties: "Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports", "Ensure periodic reviews and requalification is being performed in accordance with schedule.", "Supports equipment qualification and validation activities.", "Develops qualification protocols, and associated reports while adhering to a change management process.", "Author and review the Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.", "Responsibilities include execution of validation lifecycle maintenance that includes establishment of validation document hierarchy, tracking execution work arising from change controls, shutdown/changeover management related to validation, and management of the revalidation and cleaning monitoring programs, if necessary.", "Execute work arising from change strategy, risk assessment, testing and compliance gaps.", "Executes portfolio of limited scope and complex validation projects under strict deadlines to ensure stakeholder success and bulk drug supply.", "Maintains familiarity on BMS directives and industry guidelines on qualification/validation.", "Promotes and provides excellent customer service and support", "Regularly reviews, prioritizes, and promptly responds to end user equipment qualification and support requests.", "Provides technical support and guidance on qualification and validations issues.", "Interfaces with customers to ensure all expectations are being met.", "Maintain a positive relationship with all team members and site customers while promoting a positive team environment.", "Contributes to multi-function teams, representing validation.", "Regulatory Responsibilities Ensure alignment with BMS directives and industry guidelines on validation and quality engineering.", "May be called upon as SME in both internal and regulatory audits.", "Responsible to contribute to the preparation for regulatory inspection readiness.", "Performs other duties as assigned." We'll put these as

• . - Requirements: maybe the qualifications section? But we have Qualifications heading allowed. Could use Requirements for mandatory experience/education? But we also have Qualifications heading. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have both Requirements and Qualifications. We need to decide what goes where. Typically Requirements could be education/experience, Qualifications could be knowledge/skills. But we also have Skills heading. Let's map: - Requirements: education and experience: "Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required." "A minimum of 3+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility." "Minimum of 2+ years’ experience in equipment, facility, or utility qualification." - Qualifications: maybe "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." That's more a note. Could also include "Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level." But that's more skill. Better: Use Qualifications for the education/experience (the "Qualifications" heading). Use Skills for knowledge/skill list. Use Requirements maybe for something else? But we have limited content; we could combine Requirements and Qualifications? However we must not create empty sections. We need to decide. We have content for: - Knowledge and Skill section: many bullet-like statements: Familiarity of cGMP, direct experience with equipment, facility, sterilization commissioning and qualification, critical utilities validation, temperature mapping concepts preferred. Knowledge of distributed control systems and automation (GAMP) validation concepts suggested. Knowledge in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics / cell therapy manufacturing facility. Familiarity of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing. A working understanding of lean principles and six sigma process is preferred. Demonstrated high proficiency in project management, communication, and technical writing skills suggested. Experienced self-motivated individual who can handle multiple priorities to meet project team goals and timelines. Understands business needs and synthesizes solutions across functions. The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management. Ability to handle difficult and unusual tasks, often using creative problem-solving. Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general understanding to work within a regulatory environment. Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level. Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Strong level of problem-solving skills, verbal and written communication skills, and the ability to work independently. Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry. That's a lot; we can put under Skills. - Benefits: described. - Pay: compensation overview. - About the role: we have overview. - Responsibilities: duties. - Requirements: maybe education/experience. - Qualifications: maybe the note about hiring for skills and capabilities? Or we could treat Qualifications as the education/experience and Requirements as something else like "Minimum of 2+ years’ experience in equipment, facility, or utility qualification." But that's also experience. Better: Use Requirements for education/experience (Bachelor, 3+ years, 2+ years). Use Qualifications for the "We hire for skills and capabilities..." note? That seems weak. Alternatively, we could swap: Requirements for the note, Qualifications for education/experience. But the heading "Qualifications" is more natural for education/experience. Let's assign: - Qualifications: education and experience (Bachelor, 3+ years relevant experience, 2+ years equipment/facility/utility qualification). - Requirements: maybe the "Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level." plus other knowledge/skill? But we have Skills heading for that. Thus: - Requirements: maybe the "Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level." plus "Must have strong interpersonal and communication skills, be a team player..." etc. But those are skills. Given the ambiguity, we can combine: Use Requirements for education/experience, Qualifications for knowledge/skill, Skills for something else? But we have only three headings left after About the role, Responsibilities, Benefits, Pay. We could also omit Requirements if we don't have distinct content, but we do have education/experience. Could put education/experience under Qualifications and note under Requirements? Let's think: The instruction says "Use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It's just examples; we can choose any of those. We need to include sections only when posting has real specific content. So we need to decide which sections we have content for. We have content for: - About the role (overview) - Responsibilities (duties) - Qualifications (education/experience) - Skills (knowledge/skill) - Benefits - Pay We don't have explicit Schedule. We could omit Requirements if we don't have distinct content besides what's already in Qualifications/Skills. But we have education/experience which could go under Qualifications. The note "We hire for skills and capabilities..." could go under Qualifications as well. But we need to avoid duplication. Thus we can have sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay. We'll not include Requirements. Now we need to format. We must not repeat job title as heading. So no

  Senior Specialist, Validation Engineer II

  . We'll output HTML fragment. Let's craft:

  About the role

  At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

  Job Description PRINCIPAL OBJECTIVE OF THE POSITION: The Senior Specialist, Validation Engineer II supports the successful implementation of manufacturing, and laboratory equipment alongside facilities and utilities at multi-use sites through interaction with internal customers and external service providers. The incumbent is tasked with qualifying new equipment, facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

  Responsibilities

  • Develops and executes validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports
  • Ensure periodic reviews and requalification is being performed in accordance with schedule.
  • Supports equipment qualification and validation activities.
  • Develops qualification protocols, and associated reports while adhering to a change management process.