Sr / Principal Validation Engineer

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. The posting includes: "A Brief Overview" (maybe about the role). Then "What You Will Do" (responsibilities). Then "Qualifications" (list). Also "Base salary range" (pay). Then "Total Rewards" (benefits). Also "Corporate Social Responsibility" maybe not needed. Also "Bachem Americas is an Equal Opportunity Employer" (EEO) to be removed. Also "Plan and perform required periodic re-validation / re-qualification activities" etc are part of responsibilities. We need to preserve all substantive info, not invent. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. So we should omit the EEO paragraph. Also omit "Corporate Social Responsibility" maybe not required but could be considered not a standard heading; we could include as a paragraph under maybe "About the role"? But we should not create new headings not in list. So we could include that info under "About the role" as a paragraph? The instruction: "Prefer a few substantive sections over many thin ones." So we can combine. We need to use

for section headings. Use

• for any list of duties/requirements/benefits, and

  for prose. We need to preserve all substantive information. Let's extract sections: About the role: The first paragraph: "A Brief Overview The Sr. / Principal Validation Engineer fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations" We can put that as

  . Responsibilities: "What You Will Do" bullet list items (some are sentences). We'll convert each line to

• . Need to ensure we capture all. List items from "What You Will Do": - Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports - Perform, coordinate, execute and analyze cleaning recovery studies. - Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables. - Provide qualification / validation guidance and strategy during project planning and development phases. - Train, coach and mentor Quality Engineer I and II. - Write validation protocols and final reports, test methods, standard operating procedures, and technical reports. - Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports. - Independently conduct and document investigations related to validation studies. - Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods. - Accountable for the accuracy and validity of testing results - Support and assist with l inspections and audits. (typo: "l inspections"? maybe "I inspections"? We'll keep as is.) - Perform other related duties as assigned. - Plan and perform required periodic re-validation / re-qualification activities - Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects. - Adherence to cGMP and safety procedures and contribute to GMP systems improvements. We'll keep each as
• . Requirements: The posting has "Qualifications" heading with bullet list of qualifications. That could be considered Requirements or Qualifications. We have both headings possible. We need to decide: The posting includes a "Qualifications" section with bullet list. We could map that to either "Requirements" or "Qualifications". Since we have both headings allowed, we could put the bullet list under "Qualifications". The "Requirements" heading could be omitted if no specific content besides qualifications. But we have qualifications details; we could put them under "Qualifications". The "Requirements" could be omitted. But we also have "Skills" maybe not explicitly listed; we could infer some skills from qualifications but better not to invent. So we omit Skills. Pay: Base salary range given. We'll create

  Pay

  with

  containing the salary ranges. Benefits: "Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days." That's benefits. We'll put under

  Benefits

  with

  . Schedule: Not mentioned. So omit. Also we might include "About the role" heading. We need to ensure we don't repeat job title as heading. Not. We need to output only HTML fragment, no /, no markdown fences. Let's construct:

  About the role

  A Brief Overview The Sr. / Principal Validation Engineer fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations

  Responsibilities

  • Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports
  • Perform, coordinate, execute and analyze cleaning recovery studies.
  • Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables.
  • Provide qualification / validation guidance and strategy during project planning and development phases.
  • Train, coach and mentor Quality Engineer I and II.
  • Write validation protocols and final reports, test methods, standard operating procedures, and technical reports.
  • Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.
  • Independently conduct and document investigations related to validation studies.
  • Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.
  • Accountable for the accuracy and validity of testing results
  • Support and assist with l inspections and audits.
  • Perform other related duties as assigned.
  • Plan and perform required periodic re-validation / re-qualification activities
  • Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.
  • Adherence to cGMP and safety procedures and contribute to GMP systems improvements.

  Qualifications

  • Bachelor's degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent)
  • Master’s degree in science related field (engineering, chemistry, biology or equivalent). (preferred)
  • 5+ years of Commissioning, Qualification and Validation (CQV) experience in a GMP/GDP environment
  • Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units
  • Experience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations (preferred)
  • Experience with developing coupon spike and recovery studies for cleaning validation
  • Experience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems
  • Understanding of cleaning validation requirements for pharmaceutical industry
  • Knowledge of and ability to perform MAC calculation for APIs
  • Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.
  • Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo, including use of chemicals and their interactions, danger signs, production techniques, and disposal methods.
  • General lab instrumentation knowledge and operation experience.
  • Capable of working methodically and adhering to rules and regulations.

  Pay

  Base salary range: Sr Engineer: $103,939 - $142,916 Principal Engineer: $120,875 - $166,204 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

  Benefits

  Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

  We should also maybe include "Corporate Social Responsibility" as a paragraph under maybe "About the role"? But not required. The instruction: "Prefer a few substantive sections over many thin ones." Could add a short paragraph under About the role about CSR. But we risk adding content not originally under that heading. However we could incorporate it as a separate paragraph after About the role but without a heading? 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 "Prefer a few substantive sections over many thin ones." It might be okay to add another heading like "Corporate Social Responsibility" but it's not in the list; better to avoid creating new headings not listed. Could incorporate that info into About the role as an extra sentence. Let's see if we want to preserve that info: "Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem." That's substantive. We should preserve it. Where to put? Could add a paragraph after About the role but before Responsibilities, maybe as part of About the role. Since About the role is about the role, CSR is about company, not role. But we could add a separate heading "Company Overview" but not in list. Better to incorporate into About the role as an additional paragraph, though it's not strictly about the role but still substantive. The instruction: "Preserve ALL substantive information". So we need to include it somewhere. We could add a

  after About the role but before Responsibilities, without a heading? That would be a stray paragraph not under a heading. The instruction says use

  for section headings (list). It doesn't say you cannot have paragraphs outside headings, but likely they expect each section to have a heading. However we could add a heading "About the company" but not in list. Might be considered creating a heading not in the list, which they said to prefer few sections over many thin ones, but didn't forbid other headings. However they gave examples of headings; they didn't say you cannot use others. Safer to add a heading "About the company" maybe but it's not in the list; risk. Could we incorporate CSR into Benefits? Not really. Could incorporate into Qualifications? No. Maybe we can add a heading "About the role" and include CSR as a second paragraph within that section, even though it