Senior Specialist, Vaccines Technology
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Requirements: Could be "Required Qualifications" and maybe "Preferred" as separate? But we should avoid thin sections. Could combine qualifications and skills into Requirements and Skills sections. The instruction: Prefer a few substantive sections over many thin ones. So we could have sections: About the role, Responsibilities, Qualifications (combining required and preferred qualifications), Skills (combining required and preferred skills), Benefits, Pay, Schedule. Schedule: we have shift info: "Hybrid Shift 1st - Day". Also "Travel Requirements 10%". Also "Flexible Work Arrangements Hybrid". Also "Relocation: No relocation". Also "VISA Sponsorship No". Also "Employee Status Regular". Also "Travel Requirements 10%". Also "Flexible Work Arrangements Hybrid Shift 1st - Day". Also "Valid Driving License No Hazardous Material(s) n/a". This is schedule/Shift info. So we can create a Schedule section with those details.
Pay: salary range given: $106,200.00 - $167,200.00 plus bonus etc. Also mention annual bonus and long-term incentive. So Pay section.
Benefits: description of medical, dental, vision, retirement, holidays, etc.
We must not include headings with filler like "commensurate with experience". Not present.
We must not repeat job title as heading.
We must not put Job ID/requisition numbers as headings.
We must remove boilerplate: EEO statements, accommodation link, search firm, etc.
We must also remove duplicated lines.
Now craft HTML.
We'll start with
About the role
then... combined intro paragraphs. Intro paragraphs: "At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to our mission of using leading-edge science to save and improve lives around the world. Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Senior Specialist, Vaccines Technology position is responsible for providing technical support to formulation, primary filling, inspection, and/or packaging operations within our product's Points of Dispensing (POD) vaccine manufacturing facility at the Wilson, North Carolina site. This position will be an individual contributor and member of the Technical Team within the Vaccines Integrated Process Team (IPT). This will be an engineering role focused on startup of the POD vaccine manufacturing facility as well as providing future routine operational support. This role will act as the technical subject matter expert for all aspects of commissioning, tech transfer, start up, validation, licensure, and ongoing technical support for their area of assignment." That's the about role. Now Responsibilities: list each bullet. We need to extract responsibilities sentences from the block after "Responsibilities". They are separated by periods but each is a sentence. Let's list them: - Utilize technical expertise, experience, independent judgment, and decision-making to build robust processes that support consistent and reliable supply. - Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes. - Provide ownership for Manufacturing Execution System (MES) batch record and facilitate changes as needed to support business needs. - Ensure that assigned processes are developed in a robust manner and Critical Process Parameters (CPP) defined such that vaccines filled at the Wilson site consistently meets critical quality attributes. - Act as technical subject matter expert during regulatory inspections for area of assignment. - Ensure that process development and validation data is generated and documented in a manner that supports successful licensure and positive interactions with regulatory agencies. - Execute change management for the PT and provide scientific/technical justification for proposed changes to support business needs. - Investigate, determine root cause, and implement robust Corrective Action and Preventive Action (CAPAs) for any process-related compliance discrepancies noted during day-to-day activities and/or audits and escalate as per IPT management processes. - Ensure that technical startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and met. - Recommend continuous improvement, productivity, and capital projects for the IPT. - Partner with Operations, Quality, and other groups to execute projects that support the strategic goals of the IPT. - Maintain a culture of continuous improvement and MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem-solving. - Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables. Now Qualifications: combine required and preferred qualifications. Required Qualifications list: - Bachelor degree or higher in Engineering or Science, or related areas of study. - Minimum of four (4) years of direct pharmaceutical packaging experience. - Minimum of two (2) years of hands-on engineering or technical support experience in a cGMP biopharmaceutical/vaccine manufacturing environment, including direct participation in equipment validation/revalidation. - Demonstrated ability to work independently as a team member. - Demonstrated strong interpersonal skills with the ability to influence and support others through a culture of inclusion, feedback, and empowerment. - Working knowledge of current Good Manufacturing Practices (cGMPs) and of regulatory requirements as they apply to the vaccine/pharmaceutical industry. - Willing to work irregular hours to support multi-shift operation on an as-needed basis. - Experience supporting regulatory inspections including Federal Drug Administration (FDA). - Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc. Preferred qualifications (listed under "Preferred"): - Aseptic filling, qualified inspection processes, Cleaning-in-Place (CIP) and Sterilization-in-place (SIP) systems, pharmaceutical packaging and serialization/aggregation. - Leading manufacturing/packaging projects and investigations. - Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies. - Familiarity with Change Execution Management tools. - SAP/MES working knowledge. - Working in a Center for Biologics Evaluation and Research (CBER) regulated environment. - Demonstrated data analysis skills and experience setting up process control limits (advanced Excel, statistical software packages (Minitab), etc.). We'll combine into Qualifications section with maybe subheadings? But we only allowed
for section headings; we can't add subheadings. We could just list all items in a single
- . That's fine.
Now Skills: Required Skills and Preferred Skills.
Required Skills list:
- Business Management Tools
- Contractor Oversight
- Customer Service
- Detail-Oriented
- Driving Continuous Improvement
- Engineering Design
- Engineering Standards
- Facility Management
- OSHA Regulations
- Process Engineering
- Standard Operating Procedure (SOP) Writing
- Technical Problem-Solving
- Utilities Management
- Vendor Management
Preferred Skills list:
- Current Employees apply HERE (that's not a skill, it's a link; we should drop)
- Current Contingent Workers apply HERE (drop)
- US And Puerto Rico Residents Only (drop)
- Actually the "Preferred Skills" heading appears after "Preferred" but then there is a list: "Current Employees apply HERE Current Contingent Workers apply HERE US And Puerto Rico Residents Only". That seems like misplaced; maybe it's a copy-paste error. The actual preferred skills list is earlier under "Preferred". Wait the posting: after "Preferred" there is a line: "Aseptic filling, qualified inspection processes, Cleaning-in-Place (CIP) and Sterilization-in-place (SIP) systems, pharmaceutical packaging and serialization/aggregation.Leading manufacturing/packaging projects and investigations.Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies.Familiarity with Change Execution Management tools.SAP/MES working knowledge.Working in a Center for Biologics Evaluation and Research (CBER) regulated environment.Demonstrated data analysis skills and experience setting up process control limits (advanced Excel, statistical software packages (Minitab), etc.)." Then after that there is "Required Skills Business Management Tools, Contractor Oversight, Customer Service, Detail-Oriented, Driving Continuous Improvement, Engineering Design, Engineering Standards, Facility Management, OSHA Regulations, Process Engineering, Standard Operating Procedure (SOP) Writing, Technical Problem-Solving, Utilities Management, Vendor Management Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE US And Puerto Rico Residents Only". So the "Preferred Skills" heading is followed by those apply links etc. So we should ignore those as boilerplate. So Preferred Skills list is empty? Actually there is no explicit preferred skills beyond those earlier under "Preferred". So we can treat the earlier "Preferred" as qualifications, not skills. The Required Skills list is as above. There's no separate Preferred Skills list of substance. So we will have Skills section containing Required Skills only.
Now Benefits: description: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days." Also mention annual bonus and long-term incentive? That's under Pay maybe. We'll keep benefits as described.
Pay: salary range: "$106,200.00 - $167,200.00". Also mention annual bonus and long-term incentive if applicable. Also maybe mention "The successful candidate will be eligible for annual bonus and long-term incentive, if applicable." We'll include that.
Schedule: details: "Hybrid Shift 1st - Day", "Travel Requirements 10%", "Flexible Work Arr