Senior Quality Engineer - Fixed Term Contract

We need to output HTML fragment with sections: About the role? The description includes a narrative about West, mission, etc. Could be "About the role" or "About West". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Include a section only when posting has real specific content. We have content for: About the role (maybe description of company and mission). Responsibilities (Essential Duties And Responsibilities). Requirements (Education, Work Experience, Preferred Knowledge, Skills And Abilities, License and Certifications, Additional Requirements). Benefits (What We Offer). Pay? Not provided. Schedule? Not provided (though mentions onsite 5 days a week, 9-month Fixed Term Contract, travel 10%). Schedule could be inferred? It says onsite 5 days a week, but schedule not explicit hours. Might include "Schedule" if we have specific content: "This is an onsite position requiring the team member to be onsite 5 days a week." That's schedule info. Also "This is a 9-month Fixed Term Contract." That's contract duration, not schedule. Travel requirements also. But schedule section maybe we can include "Onsite 5 days per week". However instruction: never emit a heading followed by filler/placeholder text. So if we have real specific content, we can include Schedule section with that info. Similarly Benefits we have "What We Offer" list. Pay not provided, so omit Pay section. We must not repeat job title as heading. No Job ID etc. Remove boilerplate like EEO, accommodation, background screening, equal opportunity, etc. Also remove duplicated lines like "No relocation is provided for this opportunity" appears twice; we can keep once maybe in description but it's minor metadata; we can fold into a short p or drop. Probably drop it as minor metadata. We need to preserve all substantive information. So we need to include the company story/mission paragraph. That's substantive. Also the 9-month Fixed Term Contract, onsite 5 days a week, no relocation (maybe minor). We'll include that in About the role or a separate "Details" section? But only allowed headings from list. Could put that info in About the role section (since it's about the role). Or we could create a "Details" but not allowed. So we incorporate into About the role. Responsibilities: list of duties. Requirements: Education, Work Experience, Preferred Knowledge, Skills And Abilities, License and Certifications, Additional Requirements. Could combine into Requirements section with subpoints? But we need to use

• for any list of duties/requirements/benefits. So we can have a

  Requirements

  then a
  with items covering education, experience, preferred knowledge, etc. However we need to preserve all detail; we can break into multiple
  maybe? But instruction: Use
  • for any list of duties/requirements/benefits, and

    for prose. So we can have multiple lists under the same heading? Probably okay to have multiple

    sections each preceded by a

    heading? But they said use

    for section headings. So under Requirements we could have paragraphs for each subcategory then lists. Simpler: we can have separate headings: Education, Work Experience, Preferred Knowledge, Skills And Abilities, License and Certifications, Additional Requirements. But those are not in the allowed list; but we could still use them? The instruction says use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive? It says use

    for section headings (e.g. ...). Likely they expect only those headings. So we should stick to those headings. So we need to map content to those headings. Thus we have: - About the role: includes company mission, story, 9-month Fixed Term Contract, onsite 5 days a week, no relocation (maybe minor), maybe also mention of inclusive community, etc. - Responsibilities: Essential Duties And Responsibilities list. - Requirements: Education, Work Experience, Preferred Knowledge, Skills And Abilities, License and Certifications, Additional Requirements. Could be combined into a single list? But we need to preserve detail; we can have a

    with items that each contain multiple sentences. That's acceptable. - Qualifications: maybe same as Requirements? But we have both Requirements and Qualifications as possible headings. Could split: Requirements for mandatory (Education, Work Experience) and Qualifications for preferred etc. But we need to decide. - Skills: maybe separate for Preferred Knowledge, Skills And Abilities. - Benefits: What We Offer list. - Pay: omitted. - Schedule: Onsite 5 days a week, 9-month Fixed Term Contract, Travel 10% (up to 26 business days per year). Could include schedule details. We must not create sections with filler. So we need to ensure each heading has real content. Let's draft:

    About the role

    West is a dedicated team connected by a purpose to improve patient lives, with a heritage dating back to supplying penicillin in mass quantities during WWII. The role is a 9‑month Fixed Term Contract, onsite position requiring the team member to be onsite 5 days per week. No relocation is provided for this opportunity. West supports the physical, mental, emotional and financial health of team members and their families, encourages volunteerism, and is committed to sustainability and a healthier planet.

    That seems good.

    Responsibilities

    • Responsible for compliance to West’s validation program.
    • Ensure that validation requirements are documented to provide direction for meeting the validation needs of customers, associated regulatory bodies and West functional groups.
    • Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation.
    • Demonstrate hands‑on experience planning, establishing and executing software validation activities.
    • Support Engineering and Operations groups during the process development and Validation phases of customer products’ life cycles.
    • Provide required training to support qualification activities.
    • Assume QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc.).
    • Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions.
    • Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling.
    • Monitor Change Control system and provide guidance for proper execution and timely closure of Change Controls and Action items.
    • Understand and facilitate Risk documentation to ensure compliance with ISO 14971 and ISO 31000.
    • Ensure compliance with Quality, Business Continuity, Safety and Environmental standards and applicable regulations.
    • Experience with risk management and task prioritization is required.
    • Perform other duties as assigned.

    Requirements

    • Bachelor's Degree in Engineering or Science, or equivalent experience required.
    • 5+ years of relevant work experience required.

    Skills

    • 2+ years of experience writing, executing and summarizing protocols.
    • Knowledge of FDA, cGMP, ISO and Clean Room standards.
    • Knowledge of validation of automated assembly, software, and manufacturing processes.
    • Knowledge of ANSI/ISO standards.
    • Excellent written and verbal communication skills.
    • Good problem‑solving skills and ability to function independently or as a member of a team.
    • Awareness of all relevant SOPs as per Company policy as they relate to the position.
    • Ability to support and contribute in Lean Sigma programs and activities towards delivery of set targets.
    • Ability to comply with the company’s safety and quality policies at all times.

    Benefits

    • Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
    • Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill‑certification initiatives.
    • Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work‑life balance and recharge effectively.
    • Global Career Opportunities: With facilities across North America, Europe, and Asia‑Pacific, employees have opportunities for international exposure and cross‑functional collaboration.
    • Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
    • Recognition & Rewards: Performance‑based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

    Schedule

    • Onsite position requiring the team member to be onsite 5 days per week.
    • 9‑month Fixed Term Contract.
    • Travel requirement: up to 10% (approximately 26 business days per year).
    We must ensure we didn't include any boilerplate like EEO, accommodation, background screening, etc. We removed those. Check for any duplicated content: we included "No relocation is provided for this opportunity" in About the role. That's okay. Check for any placeholders like "commensurate with experience" - none. Check for any missing substantive info: we included the company story, mission, etc. We included the 9-month Fixed Term Contract, onsite 5 days, travel. We included responsibilities list. We included education, experience. We included preferred knowledge, skills, abilities. We included license and certifications? Wait we omitted license and certifications. That's substantive. We need to include that somewhere. Could add under Requirements or Skills. Since we have Requirements (education, experience) and Skills (preferred knowledge etc). License and certifications is also preferred. Could add under Skills as another bullet. Let's add:
    • Manufacturing/Six Sigma Green Belt Certification or Black Belt upon hire, preferred.
    • Quality/Certified Quality Technician‑ASQ (CQE or CQA) upon hire, preferred.
    • ISO 17025 Auditor or Lead Auditor Training / Certification upon hire, preferred.
    Add to Skills list. Also we omitted "Additional Requirements" like strong quality first mentality, communication, multi-task, etc. Those are also substantive. Could add under Skills or Requirements. Since they are more like abilities, we can add to Skills list. Let's add bullets for those:
    • Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
    • Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
    • Ability to work independently, multi‑task and thrive in fast‑paced environment.
    • Strong problem‑solving skills including root cause failure analysis methods.
    • Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
    • Maintain the ability to work well with others in a variety of situations.
    • Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
    • Ability to multi‑task, work under time constraints, problem solve, and prioritize.
    • Ability to make independent and sound judgments.
    • Observe and interpret situations, analyze and solve problems.
    That's a lot but preserves all. We must ensure not to create overly thin sections; but we have substantive content. Now check for any leftover