Business or Systems Analyst

Job Title : Business or Systems Analyst
Job Location:Warren, New Jersey
Job duration: 7 months
Job Description:

• The primary focus of the Systems Analyst will be to define, develop, deliver and support GXP and non GXP Enterprise and Stand-Alone computerized systems associated with Cell Therapy Clinical manufacturing and development.
• This role will have a primary emphasis on support computerized systems (Labware LIMS, Flow Cytometry, PCR and ELN) and will work effectively with other IT groups, engineers and the business stakeholders to support computer systems in both manufacturing and development.

• Collaborate with other Digital Plant leaders to address issues; develop plans to drive down support volumes for Cell Therapy benchtop IT systems.
• Manage organizational adoption of client's standard processes and systems including Vitalize; continuously enhance existing processes to simplify support requirements.
• Foster business and enterprise partner relationships to ensure a high customer satisfaction rating.
• Represent Benchtop IT (both Manufacturing, QC and Product Development) systems during internal audits and regulatory inspections.
• Provide updates to management through established mechanisms.
• Actively participate in all phases of application implementation, including the ownership of key deliverables IQ/OQ/PQ/UAT documents.
• Assure quality customer service to all customers, promote positive service relationships and contribute to supportive and cooperative work environment
• Assist project teams with technical issues in the Initiation and Planning phases of System Validation Lifecycle.
• These activities include the definition of needs, benefits, and technical strategy; research and development within the project life cycle; technical analysis and design; and support of operations staff in executing, testing and rolling-out the solutions

• Manage vendor relationships as needed, ensure support is available to the Warren Cell Therapy Facility.
• Ensure all systems are consistently maintained in an audit ready state.

• Bachelor's degree or equivalent experience in a technology or engineering focused domain.?
• A minimum of 5 to 7 years of lab and quality systems and laboratory instrument PC support or related experience, documented by a solid history of technical accomplishments and a proven track record in implementing system software.
• Commanding knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices
• Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the ability to work and manage within a regulatory environment.
• Proven implementation and life cycle planning of lab and quality systems or similar), support of cyber security actions, upgrade of instrument PCs and peripherals.
• Understanding of network, databases, servers, and PCs.
• Proven leadership skills and the ability to negotiate in a complex environment.
• Excellent verbal and written communication skills.
• Demonstrated Project Planning and Management skills

• Basic computer hardware and networking experience: 3 to 5 years
• Cell Therapy: 0 to 2 years
• Computer troubleshooting: 6 to 10 years
• GXP System Validation/21CFR Part 11: 6 to 10 years
• Labware LIMS: 3 to 5 years