Functional Engineer

Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remote per week

Functional Engineer

A Functional Engineer, also known as a Functional Analyst or Functional Consultant, plays a critical role in organizations by bridging the gap between business needs and technical solutions.

AstraZeneca is looking for a Standards IT Functional Engineer to join the Operational Clinical Development team to implement, configure and maintain the R&D Clinical Standards suite of applications. Favorable candidates for this position will have IT experience, are technology-forward thinking, and have implemented or used cloud-based software in the Content Management and Regulatory Processes.

This role requires understanding of and to work with the Clinical Standards applications and other AZ configured Integration Platforms such as MuleSoft, SnapLogic and GlobalScape to enable, automate and streamline end to end business processes, workflows configured within the Platform.

This role will contribute roadmaps, technology standards, technical design and delivery against the platform and associated resource capacity and communicate to leadership and stakeholders. You will be the expert in how this technology and platform is implemented and consumed in the business. In close collaboration with the architecture and capability teams you ensure that the solutions are up to date.

This Functional Engineer role will be part of the DevOps Platform team across the globe, based out of one of AstraZeneca’s key locations. This role will be contributing to releases, Impact Analysis, Environment readiness and providing multiple resolutions to a problem associated with Information Management.

 As part of this role, this role will be working with Product teams to optimize the release approach to ensure alignment to Platform governance, set and lead the Release Schedule, and coordinate backlog management.  The role will evaluate dependencies and mitigate risks between upstream and downstream systems affecting agreed release scope, schedule, and quality based on product roadmaps.

Here are some key responsibilities and skills typically associated with a Functional Engineer role:

Key Responsibilities

Requirements Gathering and Analysis:

• Act as a trusted Clinical Standards platform consultant and expert, providing guidance to IT and business stakeholders across Clinical, Regulatory, and Quality functions.
• Analyze and evaluate business processes to identify areas for improvement to streamline processes and enhance business value.

Solution Design:

• Design functional specifications and solutions that meet business needs through collaboration with Business and IT stakeholders.
• Collaborate with technical teams to ensure the feasibility and alignment of proposed solutions.
• Evaluate Standards Platform releases, conduct assessments/POCs, and develop business cases for implementing new enhancements and configurations to align with enterprise needs.

System Configuration and Testing:

• Configure systems and processes based on functional specifications.
• Develop and execute test plans to ensure the system meets the business requirements.
• Identify and resolve any functional issues that arise during testing.

Implementation and Support:

• Assist in the implementation of solutions, including data migration and system integration.
• Provide ongoing support and training to end-users to ensure effective use of the system.

Documentation and Reporting:

• Prepare detailed and comprehensive documentation, including process flows, functional specifications, and user manuals.
• Generate reports and analytics to support decision-making processes.

Requirements

• Biotech/Biopharma industry experience, relative to: Clinical, Regulatory & Quality Solution.
• Experience in Agile methodology.
• Experience with system testing
• Analytical Skills: Ability to analyze complex business processes and translate them into technical requirements.
• Communication Skills: Strong verbal and written communication skills to effectively interact with stakeholders and technical teams. This includes excellent customer service attitudes and interpersonal skills. Be a client facing representative for the Standards team.
• Problem-Solving: Aptitude for identifying problems and developing innovative solutions.  Troubleshoot critical production issues affecting end-users.
• Technical Proficiency: Familiarity with relevant software and tools, such as Jira, Confluence, Clinical Data Repository (CDR), and Report Annotations. Experience in cloud / hosted software environment.
• Project Management: Ability to manage projects, timelines, and deliverables. Proven ability to manage diverse stakeholders and ensure delivery to a high degree of satisfaction across diverse stakeholders.

Industry-Specific Knowledge

• Applicants should have relevant experience in the pharmaceutical industry with knowledge of end-to-end clinical standards and IT Agile Framework.
• Knowledge of Clinical Trial processes across pharmaceuticals, device and/or biotech sectors, specifically as they relate to document and data collection.

Education:                   

• Bachelor’s degree, preferably in Life Sciences, Biotechnology, Pharmacy, Biomedical engineering, Computer Engineering, Electrical Engineering, Computer Science, Information Technology, or equivalent.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.