Job Description

Are you looking for an opportunity to apply and further develop your digital and leadership skills while working in a vibrant, dynamic, and fun environment , and contribute to the growth and success of our site ? If so, this could be the job for you! 

As EBR Designer, you will be responsible for the development, creation, update, and testing of electronic batch records in the Siemens OpCenter platform .  The role participates, within a multidisciplinary project team, in the analysis and digitalization of new or existing business processes and is responsible for eliciting and gathering user requirements from the production team and converting them into an executable electronic batch record. The role is also responsible for testing, training, and documentation associated with creation and revision of the electronic batch record.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Engage process owners and stakeholders to acquire all relevant process information to allow eBR design.
• Design and create/update business process documentation for the electronic Batch Records (eBR) to support MES implementations and eBR lifecycle.
• Convert business process documentation into eBR in MES.
• Create appropriate testing and validation documentation to ensure functional and user requirements are met.
• Test and validate the eBR and associated protocols to ensure it is aligned with existing manufacturing processes
• With support from Tech and Automation, connect eBR to external systems such as OSI-PI and SAP to pull data into eBR.
• Provide support and training to end-users on the use of eBR, troubleshooting eBR issues, and support exception management (e.g. data correction in eBR).
• Drive continuous improvement of the eBR by utilizing data captured in MES, performing Gemba Walks on the shopfloor, and identifying and sharing best practices within and across sites.
• Create documentation to support LSOP creation and training materials.
• Compile and maintain relevant SAP and MES master data
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, industry practice and Industrial Excellence initiatives.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• B.S or B.A in Engineering , Computer Science, or other technical degree.
• Minimum of 3 years' manufacturing industry experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in the pharmaceutical industry
• Experience in executing projects, testing, and validation in GMP environment
• Experience in manufacturing operations.
• Experience in designing and creating electronic batch records in MES or similar.
• Experience in technical writing (e.g. validation documents, incident reports)
• Ability to create process maps for new and existing business processes.
• Ability to understand process knowledge, elicit and gather user requirements from stakeholders, and translate into business solutions.
• Proficient in MS Office applications, especially Visio & Excel
• Working knowledge of production processes in GMP environment.
• Base level coding experience with tools like VB Script, MatLab, DaX or similar programming tool (desirable)
• Base level understanding of databases (desirable)
• Customer focused, organized, and detail oriented.
• Must be able to operate independently in a high complex matrix environment. Deliverable oriented; values outcome over output.

#LI-GSK

#GSKMarietta

#MariettaGSC

Please visit  GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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, GSK may be required to capture and report expenses GSK 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 GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

Job Tags

Similar Jobs