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Validation Engineer

Company: GlaxoSmithKline
Location: Rockville
Posted on: January 24, 2023

Job Description:

Site Name: USA - Maryland - RockvillePosted Date: Dec 22 2022GSK is currently looking for a Validation engineer to join our team in Rockville, MD. The primary responsibility is to support the qualification of GxP analytical instruments, computerized systems as well as utilities and process equipment across GMS Rockville for various capital projects. Assure that the validation program is compliant with global, site and industry practices.KEY RESPONSIBILITIES:

  • Supports facility, process equipment, analytical instrument, computerized system qualification/validationactivities for various capitalprojects by writing and executingvalidation protocols and all required validation lifecycle documents ensuring compliance withcGMPsas well as above site policies and procedures.
  • Authors final reports summarizing executionofvalidationprotocols and support documents (amendments, repeat test forms, addenda and deviations).
  • Responsible for continuous improvement of validation programand assuring compliance with GSK policies and procedures.
  • Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
  • Interface with regulatory authorities and partners as the SME for the validation program.
    • Provide leadership and technical decision-making regarding cGMP compliance, validation strategy, and quality systems.
    • Schedule and coordinate validation activities withvendors,system owners,engineeringand key stakeholders.
    • Participate in change control reviews.
    • Ensure timely CAPA andchange controlexecution and closure.
    • Participates in site projects and initiatives as necessary.
      • Trainedinself inspections and participate in > 25% of department's selfinspections.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
        • BS/BA in a Scientific, Engineering, Computer Science or equivalent related discipline
        • Minimum of 3 years of industry-related experience (Validation, QA, QC, manufacturing) and 1+ year of hands-on validation experience.Preferred Qualifications:If you have the following characteristics, it would be a plus:
          • Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects of variable complexity.
          • ExperiencewithSAPandVeevais preferred.
          • Familiar with the operation and qualification of utilities, process equipment, computerized systems and analytical instruments used within biopharmaceutical manufacturing and QC labs
          • High level of IT literacy and experience with IT applicationsis preferred(SAP, Veeva,DeltaV, PLCs, Unicorn, Siemens Building Automation System, etc.).
          • Understanding of the requirements of a Biopharma/regulated environment.
          • Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
          • Extensive knowledge of 21CFR11 requirements.
          • Strong planning and program management skills.
          • Effective organization, communication, presentation and influencing skills.Why GSK?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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.#LI-GSK#GlobalSupplyChainGSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.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.At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.Important notice to Employment businesses/ AgenciesGSK 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 site.

Keywords: GlaxoSmithKline, Rockville , Validation Engineer, Engineering , Rockville, Maryland

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