Systems Analyst

SYSTEMS ANALYST WARREN, NJ Onsite. Required Skills:

• Bachelor's degree or equivalent experience in a technology or engineering focused domain.
• A minimum of 5-7 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.

• 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 & ELN) and will work effectively with other IT groups, engineers, and the business stakeholders to support computer systems in both manufacturing and development.
• Manage Benchtop IT system engineers (internal and external) at appropriate level to deliver workload.
• 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.
• 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 company standard processes and systems including Vitalize and 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 & development within the project life cycle; technical analysis and design and support of operations staff in executing, testing and rolling-out the solutions.