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The eBR Designer will design, test, and validate master batch records using Werum PAS|X Manufacturing Execution System (MES). This position will be responsible for batch record lifecycle management from creation of new records, revision, verification testing, and change management. This role will work closely with key stakeholders in a variety of departments within the eBR deployment project and lifecycle to ensure that all operational requirements are met and the execution processes are fully integrated with MERP.
This role will give YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Design, test, validate designs in Development, Pre-Prod (quality), and Production environments integrating PAS X with MERP and other automation systems using standard Middleware of MBR design
- Design, own, manage MBR, GMBR, PVL, PMBR, and ESPs in PAS-X for the eBR implementation project and Business as Usual (BaU) operations
- Gather, configure, and maintain master data in PAS-X
- Design MBR recipe equipment workflow state diagrams based on the Business process flow to logically breakdown the recipes Mfg process
- Provide user training and assist business SOP creation
- Support eBR deployment throughout the site and perform go live cutover activities and provide early life support post cutover
- Troubleshooting MBRs, system configuration, and resolve technical production issues in PASX, Middleware, and MERP providing day-to-day technical support and serving as an PAS-X subject matter expert
- Provide effective communication and drive resolution of issues by escalation/facilitation with CORE, Werum, Middleware Team, MERP, and other IT systems
- Provide input to site vision for seamless integration of eBRS into site production, compliance and reporting systems through a multidepartment collaboration
- Execute tasks assigned during change control process for eBRS production modifications, process improvements and system development while ensuring documentation reflects systems modifications
We are looking for professionals with these required skills to achieve our goals:
- High School Diploma
- 10+ years of operations experience in a pharmaceutical or cGMP facility OR 1+ years in a Quality or Technical role in a cGMP facility
If you have the following characteristics, it would be a plus:
- Bachelor's Degree in Engineering
- Familiarity with FDA / Pharmaceutical production processes, procedures equipment
- Creation, Management and Implementation of Change Controls
- Providing input to and participation in Deviation event investigations
- CAPA action generation and implementation
Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.
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At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.