IT Validation Analyst
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The role of IT Validation Analyst will be accountable for performing processes relative to the IT Software Development Lifecycle and validation services BD applications and provide GXP guidance to project groups.
This position works with the Senior Manager, IT Validation, and collaborates across TGS and among key partners from Corporate Quality, Legal, Internal Audit and Security. The aim is to ensure appropriate processes defined for TGS system development are followed in an efficient and effective manner to satisfy business and regulatory requirements.
Primary job responsibilities will include:
IT Validation –performing validation activities to implement and maintain IT systems. Provides direction related to validation topics to project teams. Authors and approves appropriate SDLC documentation to assess project teams in the development of software in a compliant manner.
IT SDLC and Operations – Collaborates with Corporate Quality, Service Management, Testing and Release Management, Security, Application, and Infrastructure teams as needed to champion the system development lifecycle and ensure the end-to-end process is effectively enabled. Advises teams in how to apply risk-based approaches and effectively plan the SDLC activities required for their systems and projects.
We are looking for an ideal candidate that will bring a combination of strategic planning, strong relationship management experience, continuous improvement mentality, strong change management and communication skills. This person should have 5+years’ experience in SDLC/Computer Systems Validation or related position in SDLC or IT Quality/Compliance activities(preferably Pharmaceutical and/or Medical Device industries).
In addition, this person should also possess:
- Experienced applying IT control methodologies and processes such as SDLC (Waterfall and Agile SCRUM), Change Management including GAMP5 and ITIL within a regulated environment.
- Knowledge of GxPs regulations for medical device products, international requirements, and quality system development and management. Explicit experience in EU regulations is a plus.
- Document Management experience using ServiceNow Managed Documents, SAP Solution Manager and/or SAP DMS/ECM a plus.
- Ability to communicate complex business / technical challenges in a simplified manner
- Build highly collaborative work style which includes working effectively globally and across all organizational levels in a highly matrixed organization
- Proven analytical, evaluative, and problem-solving abilities
- Excellent judgment and decision-making
- Strong, listening, creativity, and negotiation skills
Bachelor’s degree in IT, business, finance, or a related field is required or 10+ years of IT compliance experience
Click on apply if this sounds good!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work LocationPOL Wroclaw - Legnicka
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