Validation Process Engineer

We need to output HTML fragment with sections: Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We need to parse the posting. First, there is a Position Summary: includes Work Schedule: M-F 8am-4:30pm 100% on-site. So we have schedule info. Also maybe pay? Not mentioned. Benefits: later "Why you should join Catalent:" includes benefits: 152 hours PTO + 8 paid holidays, generous 401K match, medical/dental/vision benefits effective day one, tuition reimbursement. Also maybe other benefits like career path, inclusive culture, etc. Those are benefits. We need sections: About the role (maybe position summary?), Responsibilities (the role bullet list), Requirements (The Candidate bullet list), Qualifications (maybe overlapping with Requirements? The posting has "The Candidate:" includes BS Engineering etc. Could treat as Requirements. Qualifications maybe not separate; but we could combine. However we need to follow instruction: Use headings only when posting has real specific content. We can have sections: About the role (position summary), Responsibilities (The Role), Requirements (The Candidate), Benefits (Why you should join Catalent), Schedule (Work Schedule). Pay: not present, so omit. Skills: maybe not separate; could be part of Requirements. But we could include Skills if there is explicit skill list: "Strong communication and collaboration skills..." etc. That's under The Candidate. Could treat as Skills section. However we need to avoid thin sections. Let's decide: We'll have About the role, Responsibilities, Requirements, Benefits, Schedule. Possibly also Skills? But we have many skill-like items in Requirements; we could split Requirements into two: Requirements (education/experience) and Skills (soft skills). But we need to see if posting has distinct content for Skills. The Candidate section includes both education/experience and skills. Could separate but risk of thin sections. The instruction: Prefer a few substantive sections over many thin ones. So better to combine into Requirements (including education, experience, skills). So we will have sections: About the role, Responsibilities, Requirements, Benefits, Schedule. Now we need to extract content. About the role: Should be position summary paragraph: "Work Schedule: M-F 8am-4:30pm 100% on-site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The Validation Process Engineer supports GMP equipment and process validation activities from requirements definition and vendor selection through installation, qualification, and performance verification to ensure systems meet user needs and regulatory expectations. Manages capital projects (budget, timelines, FAT/SAT) while authoring and executing risk assessments, validation protocols, and controlled documentation (e.g., IQ/OQ/PQ, PPQ, VSR) and coordinating training for operations and maintenance. Supports commercial client onboarding owning process capability assessments, FEMAs, validation master plans, process performance qualifications and final product specifications. Provides technical support for change control, deviations/CAPA, audits, continuous improvement initiatives, and commercial client onboarding." That is a lot; we can keep as paragraph(s). Might split into multiple

but okay. Responsibilities: The Role bullet list: Starting after "The Role:" then list of duties. We'll extract each sentence as list item. Let's list them: - Develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, and oversee build, and ensure that equipment meets functional requirements. - Submit capital requests and manage project budget/timelines to completion. - Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed. - Prepare/execute/review FMEAs, Risk Assessments, Performance Verifications (PV), Engineering Studies (ES), Validation Plans (VP), System Impact Assessments (SIA), Data Integrity Assessments (DIA), Requirement Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration Qualifications (CQ), and Process Performance Qualifications (PPQ). - Author Procedures and Work Instructions for equipment operation. - Coordinate and train operations and maintenance personnel. - Perform periodic reviews and requalifications. - Participate in site safety team initiatives. - Participate in Gemba Walks, Kaizens, Lean Six Sigma, and other continuous improvement projects/initiatives. - Lead and/or provide technical support for management of change forms (MOCs), deviations, change controls, CAPAs and audit findings. - Provide validation support for the onboarding of commercial clients. - Perform other duties as assigned. We'll put each as

. Requirements: The Candidate bullet list: - BS Engineering or relevant science degree required. - 1 - 5 years of GMP process, equipment, and/or facility engineering validation experience. - Client facing project management experience a preferred. - Lean six sigma training/certification, preferred. - Demonstrated ability to write and execute technical documents and validation protocols in compliance with cGDP and cGMP requirements. - Ability to read, understand, and apply SOPs and regulatory requirements to perform daily tasks in a regulated manufacturing environment. - Strong communication and collaboration skills, including written and verbal communication, presenting to groups (virtual and in person), and working effectively as part of a team to develop solutions. - Strong organizational, problem‑solving, and decision‑making skills, with the ability to manage multiple priorities, work under pressure, and apply a working understanding of basic machine functionality (e.g., PLCs, servo motors, controls, pneumatics). - Physical Requirements: Ability to stand, walk, sit, kneel, and reach frequently, occasionally lift, push, and pull up to 25 lbs, and climb ladders or steps as needed, while working in environments with temperature variation (including refrigerated and freezer areas), noise, humidity, and potential hazards; role also requires successful completion of background and DEA screening and up to 5% travel for trade shows and factory acceptance testing. We'll include as list items. Benefits: "Why you should join Catalent:" paragraph includes: - Defined career path and annual performance review and feedback process - Diverse, inclusive culture - Positive working environment focusing on continually improving processes to remain innovative - Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives - 152 hours of PTO + 8 paid holidays - Generous 401K match - Medical, dental and vision benefits effective day one of employment - Tuition Reimbursement - Let us help you finish your degree or start a new degree! - 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. (some fragment) But we need to keep substantive info; we can list as bullet points. Schedule: Work Schedule: M-F 8am-4:30pm 100% on-site. We'll put as

. Now produce HTML fragment with

headings and

• for lists,

  for prose. We must not include job title heading. Also not include Job ID etc. We need to ensure we don't include boilerplate like EEO etc. We removed. Now produce final HTML. Let's craft:

  About the role

  Work Schedule: M-F 8am-4:30pm 100% on-site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The Validation Process Engineer supports GMP equipment and process validation activities from requirements definition and vendor selection through installation, qualification, and performance verification to ensure systems meet user needs and regulatory expectations. Manages capital projects (budget, timelines, FAT/SAT) while authoring and executing risk assessments, validation protocols, and controlled documentation (e.g., IQ/OQ/PQ, PPQ, VSR) and coordinating training for operations and maintenance. Supports commercial client onboarding owning process capability assessments, FEMAs, validation master plans, process performance qualifications and final product specifications. Provides technical support for change control, deviations/CAPA, audits, continuous improvement initiatives, and commercial client onboarding.

  Responsibilities

  • Develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, and oversee build, and ensure that equipment meets functional requirements.
  • Submit capital requests and manage project budget/timelines to completion.
  • Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed.
  • Prepare/execute/review FMEAs, Risk Assessments, Performance Verifications (PV), Engineering Studies (ES), Validation Plans (VP), System Impact Assessments (SIA), Data Integrity Assessments (DIA), Requirement Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), Configuration Qualifications (CQ), and Process Performance Qualifications (PPQ).
  • Author Procedures and Work Instructions for equipment operation.
  • Coordinate and train operations and maintenance personnel.
  • Perform periodic reviews and requalifications.
  • Participate in site safety team initiatives.
  • Participate in Gemba Walks, Kaizens, Lean Six Sigma, and other continuous improvement projects/initiatives.
  • Lead and/or provide technical support for management of change forms (MOCs), deviations, change controls, CAPAs and audit findings.
  • Provide validation support for the onboarding of commercial clients.
  • Perform other duties as assigned.

  Requirements

  • BS Engineering or relevant science degree required.
  • 1 - 5 years of GMP process, equipment, and/or facility engineering validation experience.
  • Client facing project management experience a preferred.
  • Lean six sigma training/certification, preferred.
  • Demonstrated ability to write and execute technical documents and validation protocols in compliance with cGDP and cGMP requirements.
  • Ability to read, understand, and apply SOPs and regulatory requirements to perform daily tasks in a regulated manufacturing environment.
  • Strong communication and collaboration skills, including written and verbal communication, presenting to