Senior Validation Engineer
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Sep 24 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.
- 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
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.
Our values and expectationsare 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.
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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.
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