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Specialist Business Analyst
Aditi Consulting
- 🇺🇸 United States
- On-site
- 7 hours ago
- $43 – $44 / hour
- Risk Management
- Agile
- Change Management
- GMP
- Scrum
- AI
- Pension
7 hours ago
Summary:
The Specialist Business Systems Analyst will be a key member of the programming team working towards the implementation of Product Lifecycle Management (PLM). As a part of this cross-functional team within the Combination Product Operations (CPO) organization, you would assist with the deployment of the 3DEXPERIENCE PLM platform from Dassault Systems, that will help digitize combination product design, development, and technology transfer to company’s manufacturing network. The CPO Digital team is one of a network of digital teams focused on implementing state-of-the-art digital capabilities transforming the business by improving efficiency and speed, while reducing the cost of developing, manufacturing, and distributing combination products to our stakeholders and patients.
Responsibilities:
- Generate reports and communicate insights to both technical and non-technical stakeholders.
- Document, assess, and analyze current-state business processes associated with FDA 21 CFR 820.30 design controls, including design inputs, risk management, design outputs, workflow execution, and end-to-end traceability, to identify gaps, optimize processes, and drive continuous improvement initiatives.
- Build and maintain a network of business and technical Subject Matter Experts (SMEs) to understand stakeholder needs, identify pain points, and drive alignment on process transformation initiatives.
- Facilitate workshops, interviews, and working sessions to elicit, analyze, and document business requirements, business rules, and future-state process designs.
- Translate business needs into clear user stories, functional requirements, process flows, acceptance criteria, and other delivery-ready artifacts.
- Create, prioritize, refine, and maintain a stack-ranked product backlog for one or more Agile product teams, ensuring alignment with business value and strategic objectives.
- Partner with Product Owners, Solution Architects, Developers, and SMEs to design solutions and provide ongoing requirements clarification throughout the development lifecycle.
- Support solution delivery by validating requirements, developing test scenarios, coordinating User Acceptance Testing (UAT), and managing defect resolution activities.
- Collaborate with stakeholders to ensure delivered solutions meet business requirements, operational needs, and intended business outcomes.
- Support deployment, business readiness, training, change management, and continuous improvement activities to drive successful adoption and ongoing optimization of business processes and systems, including assisting Product Owners with business workflow documentation and work-instruction updates following system releases and rollouts.
- Support digital thread enablement (digitalization of experimental and operational workflows) and FAIR data practices.
- Retrieving/processing and visualization of data
Basic Qualifications:
- Master’s degree and 2+ years relevant work experience OR
- Bachelor’s degree and 3+ years relevant work experience
- Degree in Mechanical/ Chemical/ Biomedical Engineering or related field
- Prior understanding of Good Manufacturing Practices (GMP) requirements and their implication on software deployment
- Prior experience in the medical device/pharmaceutical/medical manufacturing industry
- Experience in Agile/Scrum
- Demonstrated prior work experience as a business systems analyst in the implementation of PLM and successful training and onboarding of users onto a PLM platform in a large multi-national company.
- Experience in a product development/commercialization function
- Strong communication and cross-functional collaboration skills - ability to distill, craft and present key messages relative to diverse audience requirements.
- Demonstrated ability to work in a highly matrixed team environment.
Preferred Qualifications:
- Demonstrated capability to influence and drive change with impacted stakeholders.
- Passion for proactively identifying opportunities through business process analysis and modeling
- Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
- Ability to manage multiple, competing priorities simultaneously
- Ability to work in highly collaborative, cross-functional environments
- Strong problem solving, trouble shooting, and communication skills
- Experience with Agile Software development processes is a plus
- Familiarity with data querying and visualization tools
Top Must Have Skills:
- Experience in biotech, pharma, medical device, or a similar regulated product or manufacturing environment, ideally with PLM or other business systems.
- Business analysis experience that connects business users and technical teams, including understanding processes and translating business needs into system changes.
Pay Transparency: The typical base pay for this role across the U.S. is: $43.00 - $44.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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Specialist Business Analyst · Aditi Consulting