Jobs · Management · Ohio

Process Engineer III - Sterile Operations (Relo Avail - Night Shift)

Resilience · West Chester, OH · 3 wk ago
Management$80k–$121k/yrFull-time
We need to output HTML fragment with sections: h3 headings for sections present. Must not repeat job title. Must not include Job ID etc. Must preserve all substantive info, remove boilerplate (cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions). Also remove "Requests for reasonable accommodation can be made..." etc (EEO). Remove "Excited about Resilience? We encourage you to apply..." (application instructions). Remove "Please review the video below..." maybe not needed? It's not boilerplate but maybe considered part of posting; but it's not a list or heading; it's prose. Could keep? It's not required but it's substantive? It's about gown qualification standards. Might keep as prose. We need sections: About the role? Not present explicitly. There's introductory paragraph: "Relocation Assistance Offered A career at Resilience is more than just a job – it’s an opportunity to change the future..." That's about company. Could be "About the role" or "About the company". The instruction: use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We should include sections only when posting has real specific content. We have Responsibilities (Job Responsibilities). We have Experience & Education (Qualifications). We have Preferred Qualifications (maybe part of Qualifications). We have Physical & Work Environment (maybe Skills? but could be its own section? Not in list; but we could put under "Requirements" or "Qualifications". However we have a list of physical demands; could be its own section "Physical & Work Environment". Not in given examples but we can still use h3 with that heading? The instruction says use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests those examples. Safer to stick to those headings. Physical demands could go under "Requirements" or "Qualifications". Benefits: we have benefits description. Pay: we have target base pay hiring range. Schedule: we have Work Schedule description. Thus sections: About the role (maybe company overview), Responsibilities, Requirements (or Qualifications), Benefits, Pay, Schedule. We must not include headings with filler text. Ensure each section has substantive content. Let's extract content. Intro: "Relocation Assistance Offered A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com" That's about company/role. We'll put under

About the role

with that paragraph. Responsibilities: The block under "Job Responsibilities" with subheadings: Process & Equipment Improvement, Validation & Technical Support, Quality Systems & Compliance, Training & Development. We need to preserve all substantive info. Use
  • for any list of duties/requirements/benefits. The responsibilities are paragraphs; we could treat each bullet as a duty? The text is not bullet list but paragraphs with bold headings. We could convert each responsibility area into a
  • containing the description. Or we could keep as

    but instruction says use

    • for any list of duties/requirements/benefits. This is a list of duties (multiple). So we should make a
        with each duty as
      • . Inside each
      • we can have the text. Let's extract each duty: Process & Equipment Improvement: - Ensures there is one technical process with centerlines, critical process parameters, material fit for use, and operating procedures that are clear and deliver a capable sterile manufacturing process across multiple assigned processes. - Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated sterile pharmaceutical manufacturing equipment. - Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities, utilization, efficiencies, and obsolescence; manages asset life cycles, develops user requirements for new asset procurement, and maintains technical relationships with equipment and material suppliers. - Leads engineering and project management across multiple assigned capital and process improvement projects, including project justification, engineering proposals, and capital planning input. Validation & Technical Support: - Ensures success criteria for technology transfer and validation are clear, and the process is capable for introduction into manufacturing. - Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports. - Authors, reviews, and approves validation and change control documents such as master plans, protocols, summary reports, and change requests. - Performs routine validation and periodic review activities, including process validation required by changes to validated sterile manufacturing processes. - Leads technical troubleshooting for assigned sterile manufacturing processes and equipment. - On-call support as required. Quality Systems & Compliance: - Identifies, develops, and manages implementation of change controls to improve processes and address root causes identified in investigations. - Performs and maintains risk management activities for new and existing sterile manufacturing processes and equipment. - Initiates deviations and performs or facilitates technical investigations and assessment of impacts across multiple assigned processes, serving as the escalation point for complex investigations. - Authors and reviews Standard Operating Procedures, Batch Records, Rework procedures, and other quality documentation. - Serves as key contact for regulatory inspections as technical process owner. - Participates in periodic product and systems review processes, including annual product reviews and biennial critical systems reviews. Training & Development: - Leads technical training, serving as the escalation point for complex training needs, for Operations, Engineering, and Maintenance on new and existing sterile manufacturing processes and equipment. - Coaches and mentors Process Engineer I and II team members on technical processes and GMP practices. Now Requirements/Qualifications: There's "Experience & Education" with Minimum Qualifications and Preferred Qualifications. Also "Physical & Work Environment". We'll combine into Requirements section maybe with sublists. Minimum Qualifications bullet points (each line starts with -). Let's extract: - Demonstrated GMP experience in a sterile or aseptic regulated manufacturing environment - not just exposure. - Hands-on, applied experience across multiple of the following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical troubleshooting, aseptic/controlled environment, unit operations, formulation, sterile fill-finish, lyophilization, autoclave/sterilization, process validation, cleaning validation, technology transfer, change control, and applied statistics. - Demonstrated proficiency in at least one of the following disciplines: automation/controls, aseptic fill-finish equipment, sterile process/materials, maintenance, or validation. - Demonstrated ability to independently lead technical troubleshooting and continuous improvement efforts across multiple processes, applying structured problem-solving to issues that extend beyond established procedures. - Demonstrated ability to coach and mentor peers on technical processes and GMP practices. - Demonstrated ability to serve as a point of escalation for complex technical issues beyond the scope of less experienced engineers. Preferred Qualifications: - Bachelor’s degree in Engineering or related science. - 4+ years of relevant experience in sterile or aseptic GMP manufacturing, with expertise in more than one of the following disciplines: automation/controls, aseptic fill-finish equipment, sterile process/materials, maintenance, or validation. - Experience in project management. - Challenges and adapts current approaches, applying independent technical judgment across projects. - Experience in Six Sigma/analytical troubleshooting skills. - Experience working in a LEAN manufacturing environment. Physical & Work Environment: - Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs, as well as occasional travel. - Physical demands may include prolonged sitting with occasional standing, walking, bending, stooping, twisting, and reaching; the ability to lift or carry up to 20 lbs; infrequent work at heights up to 5 ft; occasional exposure to noise, chemicals, and moving machinery; and working in cleanroom environments with appropriate gowning and personal protective equipment. - The role also requires specific visual acuity (including extended computer use, color vision, and depth perception) and the ability to hear and distinguish sounds consistent with interpersonal and group conversation. We could put Physical & Work Environment under Requirements as well, maybe as a separate subsection but still within same section? The instruction says use
        • for any list of duties/requirements/benefits. So we can make a
            for Requirements containing all these items. Could separate Minimum vs Preferred but not required. Benefits: paragraph: "Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs." Pay: "Our target base pay hiring range for this position is $80,000.00 - $121,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge." Schedule: "Work Schedule [examples: 8 hours - Monday- Friday; 10 hours – Monday-Thursday; 12 hour – 2/2/3] The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments." We should keep that as prose under Schedule section. Also note "Relocation Assistance Offered" at start; we could include that in About the role or maybe as a separate line. Could add a sentence: "Relocation assistance is offered." We'll incorporate. Now we must remove boilerplate: EEO, accommodation request, "Excited about Resilience? We encourage you to apply...", "Please review the video below...". Also remove "Sponsorship or support for work authorization, including visas, is not available for this position." That's maybe not boilerplate but could be considered requirement; but it's about sponsorship. Might be considered substantive? It's a limitation. Could keep? It's not a heading; it's a statement. Might be considered part of Requirements? It's about work authorization. Could include as a requirement bullet. But the instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. This is not exactly those. It's about sponsorship. Might keep. However it's near the end before EEO. Might be considered part of "Requirements". I'd keep it as a requirement bullet: "Sponsorship or support for work authorization, including visas, is not available for this position." But we need to ensure we don't include application instructions. The sentence "Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters." is application instruction; remove. Also "Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester." That's not boilerplate but maybe considered part of posting; could keep as a requirement about gown qualification. It mentions gown qualification standards earlier: "As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards." So we could keep that as a requirement bullet. The video line is extra; maybe we can keep as part of that requirement. But it's not essential; we could keep the requirement about gown qualification and drop the video line. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. The video line is substantive? It's a reference to a video; maybe not

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