Jobs · Quality Assurance · Massachusetts

Senior Specialist, Validation Engineer - CSV

Bristol Myers Squibb · Devens, MA · 1 mo ago
On-siteQuality Assurance$93k–$112k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID/requisition numbers as headings; can fold minor metadata into short p or drop. We need to extract content from posting. Let's parse: Intro paragraph about BMS culture: "At Bristol Myers Squibb, our employees often ask..." This is about the role? Could be "About the role" or maybe "About the company". We'll treat as "About the role" maybe. Then "Principle Objective of Position: Qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (MES), which support clinical and commercial manufacturing facilities. Manage protocol generation, test execution, issue resolution and approval of qualification efforts to assure readiness for intended use to meet policy and compliance requirements." That's part of role description. Then "Major Responsibilities & Duties" list. Then "Knowledge & Skill" list. Then "Compensation Overview" with pay range. Then "Benefits" paragraph. Then "How We Work" (work models) maybe not needed. Then "Supporting People With Disabilities", "Candidate Rights", "Data Protection" etc - these are boilerplate, should be removed. We need to produce sections: About the role (intro + principle objective?), Responsibilities (list), Requirements (maybe knowledge & skill?), Qualifications (maybe education?), Skills (maybe project management etc), Benefits, Pay, Schedule. But we need to avoid filler sections. We need to see if schedule is mentioned: Not explicit schedule. There's mention of flexible time off, but not schedule like full-time/part-time. Could infer full-time but not explicit. So we should not create Schedule section unless posting actually states it. It doesn't. So omit Schedule. Pay: we have compensation overview with range. So include Pay section. Benefits: we have benefits paragraph. Include Benefits. Now we need to decide what goes into each section. We must preserve ALL substantive information; do not invent or summarize away detail. So we need to keep details. We need to use

for section headings. Use
  • for any list of duties/requirements/benefits, and

    for prose. We must not repeat job title as heading. We must not put Job ID/requisition numbers as headings; we can drop them or put in a short p. We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Thus we will exclude sections like "How We Work", "Supporting People With Disabilities", "Candidate Rights", "Data Protection", etc. We also need to exclude duplicated lines: there may be duplicate sentences? Not many. Now let's extract substantive content: Intro: "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." Principle Objective: "Qualify the configuration of the Process Control System (DeltaV) and Manufacturing Execution System (MES), which support clinical and commercial manufacturing facilities. Manage protocol generation, test execution, issue resolution and approval of qualification efforts to assure readiness for intended use to meet policy and compliance requirements." We could combine intro and principle objective into About the role. Now Responsibilities: list under "Major Responsibilities & Duties". The text: "Executes the validation efforts associated with the operation of all GMP manufacturing systems (Process Automation System, Manufacturing Execution System) in a highly automated biologics manufacturing facility. Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Process Automation System (Delta V). Manage test protocol generation, execution, issue resolution and summary report approval of required configuration changes to the site Manufacturing Execution System (Syncade). Performs assessment of validation work and executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs. Executes technical work assignments as a point of contact for project stakeholders. Provides validation support, to multi-function teams, and advises operations on validation matters. Ensures alignment with BMS directives and industry guidelines on validation. Duties may include internal compliance or efficiency improvement efforts within department." We need to put each as

  • . Now Knowledge & Skill section: It contains multiple bullet-like sentences but not formatted as list. We need to turn into list items. Content: "Knowledge of biopharmaceutical processing including a minimum of 2 years of experience developing and/or testing process automation system software (preferably Delta V batch). Experience with large scale distributed control systems desired. Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent. Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent. Understanding of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and know how to work and manage within a regulatory environment. DCS and PLC based experience, preferably gained in the pharmaceutical industry. Understanding of lean principles is a plus. Project management, communication, and technical writing skills are required. The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management. Ability to manage one’s emotions and impulses to prevent negative impact on productivity. 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." We need to separate into Requirements, Qualifications, Skills perhaps. But we must follow instruction: Use headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what goes where. Typically: - About the role: intro + principle objective. - Responsibilities: list of duties. - Requirements: maybe minimum years experience, education, etc. - Qualifications: maybe relevant experience, understanding of SOPs, etc. - Skills: project management, communication, technical writing, lean principles, etc. But we need to preserve all info; we can split arbitrarily as long as we keep all info. We must not create sections with filler text. So each section must have real specific content. Let's parse the Knowledge & Skill sentences and assign. Sentence 1: "Knowledge of biopharmaceutical processing including a minimum of 2 years of experience developing and/or testing process automation system software (preferably Delta V batch)." This is a requirement (experience). Could go to Requirements. Sentence 2: "Experience with large scale distributed control systems desired." Could be Requirements or Qualifications. Sentence 3: "Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent." This is education qualification. Sentence 4: "Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent." Could be Requirements. Sentence 5: "Understanding of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and know how to work and manage within a regulatory environment." Could be Qualifications. Sentence 6: "DCS and PLC based experience, preferably gained in the pharmaceutical industry." Could be Requirements. Sentence 7: "Understanding of lean principles is a plus." Could be Skills (nice to have). Sentence 8: "Project management, communication, and technical writing skills are required." Skills. Sentence 9: "The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management." Could be Skills or Qualifications. Sentence 10: "Ability to manage one’s emotions and impulses to prevent negative impact on productivity." Could be Skills (soft skill). Sentence 11: "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." This is more of a encouraging statement; could be placed in About the role or maybe a note. It's substantive; we should keep it. Could be placed in About the role as a closing note. Now Benefits section: we have paragraph about benefits. Let's extract: "Benefits Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits" We need to keep all that. Pay section: "Compensation Overview Devens - MA - US: $92,540 - $112,136 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance." We need to keep all that. Now schedule: Not mentioned explicitly; we should not create Schedule section. Now we need to output HTML fragment only. We'll structure:

    About the role

    ... intro + principle objective + encouraging note maybe

    Responsibilities

    • ...
    • ...

    Requirements

    • Knowledge of biopharmaceutical processing including a minimum of 2 years of experience developing and/or testing process automation system software (preferably Delta V batch).
    • Experience with large scale distributed control systems desired.
    • Relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
    • DCS and PLC based experience, preferably gained in the pharmaceutical industry.

    Qualifications

    • Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
    • Understanding of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and know how to work and manage within a regulatory environment.

    Skills

    • Understanding of lean principles is a plus.
    • Project management, communication, and technical writing skills are required.
    • The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
    • Ability to manage one’s emotions and impulses to prevent negative impact on productivity.

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