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Senior Validation Engineer

Company: GlaxoSmithKline
Location: Rockville
Posted on: September 13, 2020

Job Description:

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Share job Job description Site Name: USA - Maryland - Rockville

Posted Date: Jun 22 2020

Support computerized system validation and projects by writing and executing validation protocols ensuring compliance with cGMPs as well as above site policies and procedures.

Author final reports summarizing execution of computerized system validation protocols and support documents (amendments, repeat test forms, addenda and deviations).

Responsible for continuous improvement of the computerized system validation program and assuring compliance with GSK policies and procedures.

Interface with Validation, Quality Assurance, Engineering, IT, 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 computerized system validation program.

Schedule and coordinate validation activities with system owners and key stakeholders.

Participate in change control reviews.

Train/mentor new validation staff, ensuring complete familiarization with the program and procedures.

Participate 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:

BS/BA in a Scientific, Engineering, Computer Science or equivalent related discipline

Minimum of 7 years of industry-related experience (Validation, QA, QC, manufacturing) and

3 - 5 years of hands-on validation experience.

High level of IT literacy and experience with IT applications (SAP, QUMAS eDocCompliance, DeltaV, PLCs, Unicorn, Siemens Building Automation System, etc.)

Solid understanding of life cycle documents for CSV including URS, FRS, SDDS, Configuration Specifications, Validation Plan, Risk Assessment, etc.

Familiarity with the validation of computerized systems used within biopharmaceutical manufacturing and QC labs

Understanding of the requirements of a Biopharm/regulated environment

Extensive knowledge of 21 CFR 11 requirements

Strong planning and program management skills

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 essential to manage multiple projects of variable complexity

Solid interpersonal skills required in order to effectively communicate with all levels of the organization in various functional areas

Effective organization, communication, presentation and influencing skills.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk

Managing individual and team performance.

Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

Implementing change initiatives and leading change.

Sustaining energy and well-being, building resilience in teams.

Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

Developing people and building a talent pipeline.

Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

Budgeting and forecasting, commercial and financial acumen.

*LI-GSK

GSKBiopharm_manufacturing

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.

Full-Time, Rockville, Maryland, United States Senior Validation Engineer Full-Time, Rockville, Maryland, United States Start a career with purpose GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer.

Annual bonus based on company performance

Long term incentives and pension plan

Learning and career development

Access to healthcare & wellbeing programmes

Keywords: GlaxoSmithKline, Rockville , Senior Validation Engineer, Other , Rockville, Maryland

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