Deep understanding of a complex, high volume, high quality, regulated biopharmaceutical business environment
Deep understanding of a complex, integrated landscape of platforms, systems, applications, and databases, especially LIMS and ELN.
Effectively gather, document, elicit, and refine complex business requirements
Working with architects and engineers, help develop proposed solutions to business problems and determine feasibility and gap-fit with existing systems
Working with architects and engineers, develop business requirements into functional requirements
Gather, document, elicit, and refine user feedback during rapid prototyping, development, unit test, integration test, user acceptance test, and validation phases. Update business and functional requirements as needed.
Evaluate incoming enhancement requests for feasibility, business value, level of difficulty, and fit with existing system landscape
Maintain open communication at the site level and the organization level to ensure alignment between the IT teams and the business teams
Identify gaps in processes, training, documentation, and other areas which impact full and effective use of available systems
Assist the Project Manager with various aspects of project management
Who you are:
BS or MS in a scientific, technical, or Information Technology discipline.
Extensive experience as a professional Business Analyst in the Life Science industry
Biopharmaceutical or Pharmaceutical industry strongly preferred
Experience in a regulated industry environment
Experience working with stakeholders to develop and document high quality Business Requirements and Functional Requirements
Extensive experience with the Business Analysis lifecycle
Exposure or experience with the Project Management lifecycle
Extensive experience in a regulated environment: GMP, GLP, GAMP, 21CFR11, Qualification and Validation
Excellent written and verbal communications skills
Excellent organizational skills and logical / analytical thinking
Ability to troubleshoot and solve problems
Experience with laboratory systems such as LIMS, ELN, and CDS, especially LabWare LIMS and ELN
Job Requisition ID: 207163
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.