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Posted on : 21 March 2017
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- Our company s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain company s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients lives.
- This position will have a significant role in the success of the MES project by providing support for business process improvements and system solutions.
- The Business Analyst will serve as a liaison between business, technology teams, and support teams to translate business requirements into system requirements and configurations.
- This role is responsible for supporting the Manufacturing Execution System project team with analysis and potential implementation and support activities at the site.
- MES is a key enabler and critical component to achieving business objectives.
- The Business Systems Analyst for MES will be working cross functionally with technical and business subject matter experts.
- This role is for a hands-on person with great attention to detail and excellent people skills.
- The role will initially include the development of business requirements and supporting the work required for delivery of defined analysis and design concept activities.
- This position is expected to apply expertise to be able to translate and communicate process analysis into user requirements and user requirements into system requirements.
- The position involves using a host of in-house and industry standard applications and methodology within a GxP environment.
- This position will work with project teams made up of users, stakeholders and system owners, as well as work independently, to assure tasks are accomplished within defined timeframes at the highest quality with attention given to detail and scalability.
- Become a primary MES system resource to support the site, including developing expertise in user requirements, system configuration and integrations.
- Identify areas of continuous improvement in business processes and system interfaces pertaining to Manufacturing and related processes, with a focus on process reengineering and systems solutions.
- Elicit, document and manage business requirements using interviews, analysis of documents, requirements workshops, surveys, site visits, business process descriptions, use cases, scenarios, workflow analysis and other relevant techniques (e.g. Process Mapping, Value Stream Mapping)
- Support system owners and senior business analysts by assisting in evaluation of information gathered from multiple sources, reconciliation of conflicts, decomposition of high-level information into details, and differentiation between actual and desired user needs.
- Assist with project management tasks including SDLC documents and validation activities.
- Use excellent collaboration skills to work with cross-functional groups and contractors (locally and remotely located) to ensure successful and timely deliverables
- Perform project tracking using standard project management tools
- Communicate and work collaboratively with the US-based project team and Technical Operations global groups.
- 5 plus years in the Pharma/Life-science industry including supporting Enterprise Applications such as MES.
- Experience in pharmaceutical/life-sciences Manufacturing, Quality or Automation considered.
- Experience with MES implementation or upgrade projects preferred.
- Experience with systems implementations, including knowledge of GAMP and SDLC.
- Working knowledge of system integrations requirements, technology and design.
- Strong exposure to MES technologies, including automated data collection, visualization, quality and efficiency in manufacturing, automation, workflow, database application, scheduling, and interface to ERP and other enterprise systems.
- Strong knowledge of business processes used within the Pharma/Life-sciences industry.
- Independent business analysis and problem solving skills.
- Experience implementing business improvements through more effective use of Enterprise Applications and related software
- Very strong interpersonal and communication skills and ability to interact positively with all levels of the organization.
- Must be able to work as part of a team as well as individually
- Must be able to work with limited direction and be a self-starter and deadline focused
- Must have a desire to learn new technologies both by instruction and self-teaching
- Experience in the application of Manufacturing systems, including information exchange, integration requirements and master data.
BS in computer or engineering/sciences related discipline and significant experience in the Pharmaceutical/Life Sciences industry.
Interacts with all levels (Directors, Managers, Business users, External support staff) of the following departments:
- Information Technology
- Quality Assurance
- Manufacturing Science
- Quality Control
- Materials Operations
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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