The primary responsibility is to support the qualification of GxP systems across GMS Rockville manufacturing and laboratory areas. Assure the validation program is compliant with global, site and industry practices. Specifically, this role will be responsible for the support of Computerized System Validation at GMS Rockville.
KEY RESPONSIBILITIES: (10 bullet points maximum)
Supports system computerized system qualification/validation and projects by writing and executing validation protocols ensuring compliance with cGMPs as well as above site policies and procedures.
Authors final reports summarizing execution validation/qualification protocols and support documents (amendments, repeat test forms, addenda and deviations).
Interface with Validation, Quality Assurance, Engineering, System Owners and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
Schedule and coordinate validation activities with system owners and key stakeholders.
Participate in change control reviews.
Responsible for continuous improvement of the computerized system validation programs.
Participates in site computerized system validation projects and initiatives as necessary.
Trained in self inspections and participate in >25% of department's self Inspections.
Why You?Basic qualifications:
Minimum of 3 years of industry- related experience (Computer Science, Validation, Automation/Process Controls or IT) and 1 year or less of hands-on validation experience.
BS/BA in a Computer Science, Scientific, Engineering or computer related discipline
Familiar with the validation of computerized systems used within biopharmaceutical manufacturing and QC labs
Understands the requirements of a Biopharma/regulated environment
Able to communicate effectively with cross-functional teams of diverse people
Strong planning and program management skills
Effective organization, communication, presentation and influencing skills.
Exposure to SAP, QUMAS eDocCompliance, Quality Center ALM, DeltaV, PLCs, Unicorn, Siemens Building Automation System.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. 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.