Summary:

Individuals in this position will work with business users, other SAP Business Analysts, developers and internal IT team members on the implementation, support and enhancement of the SAP module for which they are responsible. SAP Business Analysts will serve as the functional lead for their assigned department(s). They will apply proven communication, analytical and problem solving skills to help maximize the benefit of SAP in the client environment.  Assignments are complex in nature where considerable judgment and initiative are required in resolving problems and making business process recommendations.

Essential Duties/Responsibilities:

• Develop strong partnerships with the Quality, Manufacturing, and Engineering departments in order to understand the strategic direction, business processes and business needs of the business areas and recommend processes and/or functionality in SAP that can be used to meet the requirements.
• Provide production support through design, development, testing and implementation of appropriate system configurations within primary modules of responsibility, specifically, Quality Management (QM), Materials Management (MM/WM), Production Planning (PP), and Plant Maintenance (PM), to effectively meet business requirements.
• Prepare detailed design documents, functional specifications for development activities including reports, interfaces, conversions, enhancements, and forms. Follow all internal standards and change control procedures in performing required work.
• Perform testing activities (unit, conference room pilots, integration and user acceptance testing), including test plan creation and data and test execution (in conjunction with the other functional team leads).  Promote transports to quality assurance and production.
• Prepare training materials and perform end-user training for newly implemented functionalities and enhancements.

Qualifications:

• Bachelor’s Degree  in Computer Science, Information Systems, or related discipline.
• 8-12 years of experience in  extensive configuration in MM, PP, QM and PM modules required in SAP ECC 6.x.
• Experience working with 3rd party solutions specific to the area of expertise
• Team Lead experience required
• Knowledge of entire SAP landscape for supported processes
• Experience in multiple SAP implementations preferred (at least three successful, full life cycle implementations required, preferable in a pharmaceutical environment)
• Basic understanding of ABAP programming with debugging skills.  Must have very good knowledge of working with user exits
• Strong working knowledge of Microsoft Applications (PowerPoint, Excel, Word)
• Experience within a manufacturing environment regulated by the FDA preferred
• Experience with computer systems’ validation preferred
• SAP certification preferred

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:
The Senior Business Analyst, Quality Systems (IT) position will be responsible for defining, designing, and delivering information technology solutions in a validated environment for the Quality, R&D and Manufacturing areas, with primary responsibility for EDMS systems. The Analyst will be responsible for documenting functional requirements and solution specifications, interacting with both Business users and IT resources. The Analyst will also be responsible for the administration of Veeva Vault including overseeing the managed services vendor aiding in that support. The Analyst should be familiar with the principles of computer systems validation, project and SDLC methodologies.

Responsibilities:
• Work with internal business clients to document business requirements for EDMS solutions and applications interfaced with it.
• Analyze current processes, and document configuration, application functionality and integration modifications needed to support business requirements.
• Create SDLC project deliverables including design, configuration, and testing.
• Work with software vendors to understand existing and future release functionality.
• Execute and document testing and work with team members for problem resolution.
• Provides technical assistance to users inquiries regarding errors, problems or questions.
• Perform Quality Assurance validation on requirements based software applications.
• Escalate incidents and requests as required to ensure quality service and within established service targets.
• Participate in after-hours on-call support rotation as required.
• Provide technical and procedural direction to team during manager’s absence
• Participate in knowledge transfer activities to relevant support teams for implemented solutions.

Requirements:
• 2-5 years of relevant IT experience supporting / developing systems solutions to business requirements
• 2-5 years of supporting or implementing enterprise software in a regulated (preferably Pharmaceutical/BioTech/ Medical Device) industry.
• 2-5 years of understanding of IT Quality Methodology and Change Management, including processes and tools.
• Previous Application Maintenance / Support experience a must.
• Experience with systems supporting Trackwise is a plus
• College degree (or equivalent experience)
• 2-5 years of previous EDMS experience – min 3 years. Veeva Vault experience is a plus
• 2-5 years of previous Application Maintenance / Support experience a must.
• 0-2 years of Previous Application Maintenance / Support experience a must.
• 0-2 years of Previous Application Maintenance / Support experience a must.
• 0-2 years of IT Certifications/training or equivalent experience is a plus.

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:

The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems required for drug development in the cGMP environment. This position is responsible for the business analysis, planning, project management, implementation, computer systems validation and ongoing support of business applications in the areas of Research & Development Analytical, Regulatory Affairs, Clinical, Quality Affairs and Quality Control. The position has the responsibility of building a team and managed service model for support of these business systems and is the primary interface between IT and the R&D and Quality business teams. This position reports to the Director, IT Business Services.

Responsibilities:

• Work with business users to improve existing processes to allow them to be automated and recommends business / technology solutions to various functional areas.
• Assists implementation, administer methods and procedures to enhance operations based on industry best practices
• Manages the application support of R&D and Quality systems to ensure they meet business needs and user requirements, remains in compliance per cGMP requirements and GAMP5 guidelines.
• Ensure compliance with (1) FDA regulations related to IT infrastructure (2) Ensure compliance with FDA 21 CFR Part 11 in applications (3) Ensure compliance with SOX controls by all technical staff
• Provide IT oversight for GXP computer systems validations per GAMP5 guidelines and apply risk based methodology to validation efforts.
• Follow processes and operational policies in selecting methods and techniques for obtaining solutions.
• Ensures budgets, user requirements, and schedules meet department expectations and business requirements or escalate before situation is critical.
• Helps to develop resources and innovation to match the client’s continued growth in IT.
• Responsible for providing regular performance and development feedback to direct reports
• Manage Service Level Agreement’s with customers and vendors.

Requirements:

• 8-12 years of experience with a minimum of 10+ years of previous experience in system development, integration and laboratory work in the pharmaceutical or biotech industry is required.
• Requires a minimum of 5 years previous management experience.
• Experience with laboratory automation systems / instrumentations in a pharmaceutical environment.
• Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, Manufacturing environments regulated by the FDA.
• Experience with laboratory automation systems / instrumentations in a pharmaceutical environment.
• Experience with computer network validation
• International experience with implementing quality systems.
• Experience with VMware in a regulatory environment.
• Bachelor degree in Computer Science, Information Systems, or related discipline at a minimum. Master’s Degree is preferred.
• Experience with full system development life cycle, project management in large system, enterprise scale, implementation projects and laboratory automation applications.
• Solid knowledge of network and computing systems is essential.
• Experience with Waters CDS, Trackwise, LIMS, Electronic Regulatory Filing System, Document Management, Quality Systems, Laboratory Operations.
• Experience with computer systems validation.

Position Must Be Filled By April 15, 2016, So Apply Soon!