Lead Validation Engineer

We need to output HTML fragment with sections only if content present. Use

for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to parse the posting. The posting includes: introduction about mission, role description, duties and responsibilities (long list), Education and Experience (requirements), plus some physical requirements, ability to sit/stand etc. Also mention occasional work outside normal business hours (schedule?). No explicit pay or benefits mentioned. So we should not create Benefits, Pay, Schedule sections unless present. There's mention of occasional work outside normal business hours - that could be schedule info. But it's not a specific schedule like "full-time" etc. It's a schedule condition. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state occasional work outside normal business hours, which is schedule-related. So we could include a Schedule section with that detail. However we need to ensure we don't include placeholder text. The text: "Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs." That's specific enough. So we can include a Schedule section with that as a

. Benefits: none mentioned. Pay: none. Thus sections: About the role (intro paragraph), Responsibilities (list of duties), Requirements (Education and Experience?), Qualifications maybe overlapping. The instruction: Use headings for section headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which sections to include based on content. We have: About the role: we can use the introductory paragraph(s) describing mission and role. Responsibilities: the "Duties And Responsibilities" block. Requirements: maybe the "Education And Experience" block (including degree, years experience, etc.) Qualifications: maybe the specific technical qualifications like experience performing certain qualifications, knowledge of regulations, skills etc. Could split but we can combine into Requirements and Qualifications? The instruction says prefer a few substantive sections over many thin ones. So we could have About the role, Responsibilities, Requirements (covering education, experience, qualifications, skills). Skills could be separate if we have distinct skills list. The posting includes: "Strong technical writing, problem-solving, organizational, and project management skills. Strong computer skills- familiarity with Microsoft Office, Quality Record Management, CMMS, BMS/BAS, EMS, Validation Data Management Software, CAD and ability to quickly learn new applications". Also "Ability to sit, stand, and walk regularly...". Those could be skills. But we could keep them under Requirements. Given preference for few sections, we could do About the role, Responsibilities, Requirements (including education, experience, qualifications, skills), Schedule. Let's craft. We must not repeat job title as heading. No Job ID. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details from the posting, but we can format as lists. We need to use

• for any list of duties/requirements/benefits. So for responsibilities we should make a list. For requirements we can also list. We need to ensure we don't lose any detail. Let's extract sections. Intro: "We are seeking a Lead Validation Engineer at our Germantown, MD location to join us in our mission to serve patients through innovative Gene Therapies. This position serves as a technical leader within the Validation function and provides validation engineering support for Precigen's GMP Manufacturing, Quality Control (QC), Facilities, and Research & Development (R&D) operations. The ideal candidate will possess advanced expertise in equipment, utility, facility, and process qualification within regulated GMP environments. This individual will lead complex validation projects, develop validation strategies, provide technical guidance to cross-functional teams, and ensure compliance with applicable regulatory requirements. The successful candidate will be highly organized, technically proficient, detail-oriented, and capable of independently managing multiple high-priority initiatives while driving continuous improvement across the site validation program." That's the About the role. Duties And Responsibilities: list each bullet (starting with "Provide technical leadership..." etc). We need to capture all. Let's list them: - Provide technical leadership for site validation and qualification activities supporting GMP manufacturing, laboratory, utility, and facility systems. - Lead complex qualification and validation projects from concept through implementation, including new equipment installations, facility expansions, process improvements, utility modifications, and major change control initiatives. - Serve as a Validation Subject Matter Expert (SME) for GMP facilities, utilities, process equipment, analytical instruments, and qualification lifecycle management. - Coordinate with Facilities, Metrology, Manufacturing, Quality, R&D personnel, contractors, and equipment vendors to maintain validated systems and ensure compliance with regulatory requirements. - Oversee qualification activities for facility systems including HVAC, backup power systems, water purification systems, compressed gas distribution systems, clean utility systems, autoclaves, glass washers, part washers, controlled temperature units, refrigerators, and freezers. - Provide qualification support for process and analytical equipment including incubators, biosafety cabinets, centrifuges, chromatography systems, filtration systems, PCR systems, environmental monitoring equipment, and laboratory instrumentation. - Develop validation strategies and qualification approaches using risk-based methodologies consistent with FDA, EU GMP, ISPE, ASTM, and GAMP principles. - Author, review, approve, and execute Validation Master Plans, Validation Plans, Risk Assessments, Commissioning and Qualification Plans, Protocols, Reports, SOPs, and Work Instructions. - Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for facilities, utilities, equipment, and systems. - Perform and lead Environmental Monitoring Performance Qualification (EMPQ), cleanroom qualification activities, airflow visualization (smoke studies), HVAC performance testing, and autoclave qualification/requalification programs. - Execute and review controlled temperature unit (CTU) and autoclave temperature mapping studies utilizing Kaye Validators or equivalent data acquisition systems. - Develop and facilitate risk assessments including impact assessments, failure mode and effects analyses (FMEA), and other risk-based validation methodologies. - Collect, evaluate, trend, and interpret validation data to ensure systems remain in a qualified state and are suitable for GMP use. - Provide technical oversight and review of qualification packages generated by internal personnel, contractors, consultants, and equipment vendors. - Support the site Quality Management System (QMS) through authoring, investigation, and review of qualification-related deviations, change controls, corrective and preventive actions (CAPA), and periodic reviews. - Support regulatory inspections, client audits, and internal audits as the Validation SME. - Provide hands-on troubleshooting support and collaborate with original equipment manufacturers (OEMs) and service providers to resolve complex technical issues. - Identify and implement continuous improvement opportunities that enhance compliance, efficiency, and effectiveness of validation programs. Education And Experience: list: - Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related scientific discipline required. - Minimum of five (5) years of GMP validation and qualification experience within the pharmaceutical, biotechnology, medical device, cell therapy, gene therapy, or related regulated industry. - Demonstrated experience independently leading complex validation projects and coordinating cross-functional teams. - Extensive experience with equipment, utility, facility, and process qualification programs within GMP environments. - Proven experience performing and leading: - Autoclave Qualification and Requalification - Environmental Monitoring Performance Qualification (EMPQ) - Airflow Visualization (Smoke Studies) - Controlled Temperature Unit (CTU) Qualification and Temperature Mapping - Utility Qualification (Compressed Gas, Water, and Clean Utility Systems) - Equipment IQ/OQ/PQ Activities - Experience authoring and reviewing Validation Master Plans, Validation Protocols, Validation Reports, Risk Assessments, SOPs, and Work Instructions. - Experience supporting investigations, change controls, deviations, CAPAs, and periodic reviews within a GMP Quality Management System. - Strong understanding of FDA regulations, EU GMP requirements, Annex 1, Data Integrity principles, and industry best practices for qualification and validation. - Excellent technical writing, problem-solving, organizational, and project management skills. - Strong computer skills- familiarity with Microsoft Office, Quality Record Management, Computerized Maintenance Management Systems(CMMS), Building Management/Automation Systems (BMS/BAS), Environmental Monitoring System(EMS), Validation Data Management Software, Computer Aided Design (CAD) and the ability to quickly learn new applications - Ability to sit, stand, and walk regularly to access mechanical areas and aseptically gown into production suite. Able to maneuver equipment and supplies up to 40 pounds - Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs. We need to decide where to put the physical ability and occasional work. Could be under Requirements or Skills. Since we have a Schedule section for occasional work, we could put that there. The physical ability could be under Requirements or Skills. Let's put physical ability under Requirements as part of qualifications. Thus sections: About the role:

  with the intro paragraph(s). Could be multiple paragraphs but we can combine into one

  (though line breaks lost). Might be okay. Responsibilities:

  Responsibilities

  with each duty as
  • . Requirements:

    Requirements

    with education, experience, technical expertise, understanding of regulations, skills, computer skills, physical ability. Schedule:

    Schedule

    Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.

    We must not include Benefits, Pay sections. Check that we haven't missed any detail: The intro also mentions "This position serves as a technical leader within the Validation function and provides validation engineering support for Precigen's GMP Manufacturing, Quality Control (QC), Facilities, and Research & Development (R&D) operations." included. Also "The ideal candidate will possess advanced expertise in equipment, utility, facility, and process qualification within regulated GMP environments." included in requirements maybe. Also "This individual will lead complex validation projects, develop validation strategies, provide technical guidance to cross-functional teams, and ensure compliance with applicable regulatory requirements." included. Also "The successful candidate will be highly organized, technically proficient, detail-oriented, and capable of independently managing multiple high-priority initiatives while driving continuous improvement across the site validation program." included. We need to ensure we didn't drop any of those. Let's incorporate them into requirements or about the role. The about the role already had some of that. We can keep the about the role as originally given (the first two paragraphs). That includes mission, role description, ideal candidate expertise, leading projects, etc. The later sentences about successful candidate being highly organized etc. could be placed in requirements as skills. Let's split: About the role: first paragraph: "We are seeking a Lead Validation Engineer at our Germantown, MD location to join us in our mission to serve patients through innovative Gene Therapies. This position serves as a technical leader within the Validation function and provides validation engineering support for Precigen's GMP Manufacturing, Quality Control (QC), Facilities, and Research & Development (R&D) operations." Second paragraph: "The ideal candidate will possess advanced expertise in equipment, utility, facility, and process qualification within regulated GMP environments. This individual will lead complex validation projects, develop validation strategies, provide technical guidance to cross-functional teams, and ensure compliance with applicable regulatory requirements." Third paragraph: "The successful candidate will be highly organized, technically proficient, detail-oriented, and capable of independently managing multiple high-priority initiatives while driving continuous improvement across the site validation program." We could keep all three as

    under About the role. Now responsibilities list as above. Now requirements list: need to include education, experience, etc. Also include the skills like "Excellent technical writing, problem-solving, organizational, and project management skills." and "Strong computer skills- familiarity with Microsoft Office, Quality Record Management, CMMS, BMS/BAS, EMS, Validation Data Management Software, CAD and the ability to quickly learn new applications". Also "Ability to sit, stand,