Job Number: 21171983
- 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.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Cindi: cindi@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02198
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE