Validation Analyst I

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. We must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate, navigation, legal, EEO, etc. We need to parse the posting. Let's extract sections: - About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary We have an opportunity for a Validation Analyst I to join our team. In this role, you will support validation and qualification programs across manufacturing and laboratory disciplines. You will ensure compliance with Catalent guidelines and regulatory requirements while managing validation deliverables. This position offers the chance to work on diverse projects and collaborate with multiple teams to achieve successful outcomes. Shift: Mon to Fri 8am-5pm Location: Kansas City, MO 100% Onsite That's about the role and location/shift. - The Role: list of duties. - The Candidate Minimum Requirements: list of requirements. - Preferred Skills & Background: experience in cGMP highly preferred. - Why You Should Join Catalent: benefits etc. We need to map to headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have content for About the role (site description, position summary, shift, location). Responsibilities (The Role bullet list). Requirements (Minimum Requirements). Qualifications maybe overlapping with Requirements? Could treat Minimum Requirements as Requirements, and Preferred Skills as Qualifications or Skills. Benefits from Why You Should Join Catalent. Pay: not mentioned. Schedule: shift mentioned (Mon-Fri 8am-5pm) so we can have Schedule section. We must not create sections with placeholder text. Pay not mentioned, so omit Pay section. We must not repeat job title. We must output only HTML fragment, no /, no markdown. We need to use

for each section heading. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep details like specific bullet points. Let's extract bullet points from The Role: - Ensure validation program deliverables are executed according to project objectives, timelines, resources, cost, and quality for site-level technology rollouts. - Generate, execute (where applicable), approve, and summarize validation protocols for Good Manufacturing Practice equipment and instrumentation qualification, commissioning, and other validation commitments per Catalent and regulatory standards. - Collaborate with external technology vendors, internal support groups (Site IT, Global IT, Validation, Quality Assurance) and internal business units (Manufacturing, Pharmaceutics, Analytics, Quality Control, Facilities, Engineering) to manage assigned validation deliverables. - Apply project management skills in procurement, integration, and implementation of new and upgraded laboratory software, instruments, applications, and information systems. - Participate in and support continuous improvement initiatives. - Assist in developing, training, and implementing validation policies and procedures. - Perform other duties as assigned. We'll put these in

  • . Minimum Requirements bullet list: - Bachelor's Degree in Life Sciences, Engineering, or related field. - Minimum of 2 years of validation, engineering, or related experience. - Strong and in-depth knowledge of validation, quality, and regulatory compliance. - Understanding of pharmaceutical solid dose commercial manufacturing and analytical laboratory testing. - Familiarity with current Good Manufacturing Practices, ISPE GAMP5, and validation practices of the FDA, MHRA, and similar regulatory agencies. - Clear verbal and written communication skills. - Excellent organizational skills and ability to multi-task with strong analytical problem-solving skills. - Strong technical writing skills with proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and SharePoint. - Understanding and application of regulatory compliance, vendor/client/regulatory audits, standard operating procedure development, change management, deviations, and quality system disciplines. - Ability to work effectively as part of a team and contribute to team commitments. - Understanding and application of Six Sigma principles and Project Management Professional disciplines. Preferred Skills & Background: "Experience working in a current Good Manufacturing Practice environment highly preferred." Why You Should Join Catalent bullet list (some are sentences): - Defined career path with annual performance reviews and feedback process. - Diverse and inclusive culture. - Opportunities for career growth within an organization dedicated to improving and saving lives. - Competitive paid time off plus 8 paid holidays. - Community engagement and green initiatives. - Medical, dental, and vision benefits effective on the first day of employment. - Tuition reimbursement program. - Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. - Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. - Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. - Join us in making a difference. - personal initiative. dynamic pace. meaningful work. (these seem like tagline fragments; maybe we keep as prose? Might be considered boilerplate? It's part of the "Why You Should Join Catalent" but seems like marketing fluff. We'll keep as prose maybe. We need to avoid boilerplate like EEO etc. The "Why You Should Join Catalent" includes some substantive benefits: defined career path, diverse culture, career growth, competitive PTO plus 8 holidays, community engagement/green initiatives, medical/dental/vision benefits day 1, tuition reimbursement. Those are benefits. The rest about mission etc could be considered prose but still substantive. We'll keep them as

    maybe. Shift and location: "Shift: Mon to Fri 8am-5pm Location: Kansas City, MO 100% Onsite". That's schedule and location. We'll put schedule in Schedule section. Location maybe in About the role. Now construct HTML. We'll have sections:

    About the role

    About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary We have an opportunity for a Validation Analyst I to join our team. In this role, you will support validation and qualification programs across manufacturing and laboratory disciplines. You will ensure compliance with Catalent guidelines and regulatory requirements while managing validation deliverables. This position offers the chance to work on diverse projects and collaborate with multiple teams to achieve successful outcomes. Location: Kansas City, MO 100% Onsite.

    But we need to separate shift maybe into Schedule section. Better: About the role includes site description and position summary; location maybe also there. Schedule section:

    Schedule

    Shift: Monday to Friday, 8am‑5pm.

    Now Responsibilities:

    Responsibilities

    ...
    Requirements:

    Requirements

    ...
    Qualifications: maybe we can put Preferred Skills & Background as Qualifications? Or Skills? The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Skills). So we have Qualifications and Skills separate. We could put Minimum Requirements as Requirements, Preferred Skills as Qualifications, and maybe Skills from the list (technical writing, communication, etc) but those are already in Requirements. To avoid duplication, we could treat Requirements as the bullet list of minimum requirements, Qualifications as the preferred skills (cGMP experience), and Skills maybe we could extract technical skills like Microsoft Office proficiency etc but that's already in requirements. Might be better to combine: Requirements = minimum requirements, Qualifications = preferred skills, Skills = maybe we could list technical skills like "Strong technical writing skills with proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and SharePoint." but that's already in minimum requirements. To avoid duplication, we could omit Skills section if no distinct content beyond what's already covered. The instruction: Prefer a few substantive sections over many thin ones. So we can omit Skills if not distinct. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Benefits, Schedule. Check if we have content for Qualifications: "Experience working in a current Good Manufacturing Practice environment highly preferred." That's a qualification. We'll put that as
    • Experience working in a current Good Manufacturing Practice environment highly preferred.
    Benefits: list from Why You Should Join Catalent: defined career path, diverse culture, career growth, competitive PTO plus 8 holidays, community engagement/green initiatives, medical/dental/vision benefits day 1, tuition reimbursement. Also maybe the mission statements but those are more descriptive; we could include them as

    prose. We must not include boilerplate like "Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader..." That's somewhat promotional but still substantive? Might be considered boilerplate but it's part of the "Why You Should Join Catalent". The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This promotional text is not explicitly listed as boilerplate, but could be considered fluff. However it's part of the benefits section; we could keep it as prose. We'll include a

    with the descriptive sentences about mission, etc. Now construct HTML. Make sure to use proper HTML tags, no extra whitespace issues. Let's write:

    About the role

    About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary: We have an opportunity for a Validation Analyst I to join our team. In this role, you will support validation and qualification programs across manufacturing and laboratory disciplines. You will ensure compliance with Catalent guidelines and regulatory requirements while managing validation deliverables. This position offers the chance to work on diverse projects and collaborate with multiple teams to achieve successful outcomes. Location: Kansas City, MO 100% Onsite.

    Responsibilities

    • Ensure validation program deliverables are executed according to project objectives, timelines, resources, cost, and quality for site-level technology rollouts.
    • Generate, execute (where applicable), approve, and summarize validation protocols for Good Manufacturing Practice equipment and instrumentation qualification, commissioning, and other validation commitments per Catalent and regulatory standards.
    • Collaborate with external technology vendors, internal support groups (Site IT, Global IT, Validation, Quality Assurance) and internal business units (Manufacturing, Pharmaceutics, Analytics, Quality Control, Facilities, Engineering) to manage assigned validation deliverables.
    • Apply project management skills in procurement, integration, and implementation of new and upgraded laboratory software, instruments, applications, and information systems.
    • Participate in and support continuous improvement initiatives.
    • Assist in developing, training, and implementing validation policies and procedures.
    • Perform other duties as assigned.

    Requirements

    • Bachelor's Degree in Life Sciences, Engineering, or related field.
    • Minimum of 2 years of validation, engineering, or related experience.
    • Strong and in-depth knowledge of validation, quality, and regulatory compliance.
    • Understanding of pharmaceutical solid dose commercial manufacturing and analytical laboratory testing.
    • Familiarity with current Good Manufacturing Practices, ISPE GAMP5, and validation practices of the FDA, MHRA, and similar regulatory agencies.
    • Clear verbal and written communication skills.
    • Excellent organizational skills and ability to multi-task with strong analytical problem-solving skills.