The Associate Director of Information Technology is a leadership position that will plan, direct, and be responsible for the Software system lifecycle:
- Selection
- Designandconfiguration,
- Validation
- Deployment,
- Upgrade andmaintenance,
- Continuous improvementand
- Decommissioning
The major software system in deployment is the Material Management and Manufacturing Execution System (MES), currently POMS. Responsibility will also include support for systems such as the QMS, label printing, validation and equipment software.
The role will manage the local IT support team. The individual will work in close collaboration with the site business teams and the Global IT Infrastructure, support and security team.
How You Will Make an Impact:
Leadership and management:
- Leadthe site ITS team and representthe ITS on the site leadership team.
- Responsible for developing and managingUSsite ITbudget.
- Ensure the achievementofsitedigitaltransformationand globalITgoalssuch assystem implementation,infrastructure, desktop support and cyber security.
Software development and management
- Manage relationships withGMPtechnology vendors, solution providers, consultants, and outsourcing firms. Manage consulting engagements to achieve both stakeholder satisfaction and costs.
- Negotiation and relationship management forGMPtechnology partners, including initial and annual due diligence, renewals and pricing, technology comparisons, and evaluations.
- Support integration, validation, administration, and maintenance activities of the site's GMP computer systems.
- Be a site leader in cGMP manufacturing software technologyconfiguration and deployment,develop technical expertise, conduct on-site training, etc.
- Stay informed about strategic and emerging technologies. Adopting and implementing new technologies/services where it can deliver meaningful value toRoslinCT.
Manufacturing Execution System
- Function as a site technical expert for all questions and issues related to the MES system supporting the manufacturing of cell therapy products.
- Performand direct thedesign, configuration, and recipe authoring activities of the site's MES application.
- Directly support operations with troubleshooting and issue resolution with respect to the MES system.
- Lead MES projects to meet deliverables, technical, budget, and schedule goals including managing the work of internal and external resources and following up to ensure the desired result has been achieved.
- Support the life-cycle maintenance of GMP manufacturing systems includingdeveloping programs forsoftware backups, updates, diagnostics, documentation, and obsolescence planning.
- Capable of being an MES subject matter expert to assist in regulatory audits and investigations.
Qualifications;
- BS inComputer Science,Engineering, Engineering Technology, or other Technical Degree with a minimum of7years' experience working in a regulated GMPenvironment, preferably in biopharmaceutical manufacturing.
- Evidence of teamwork, leadership and initiative takingincluding management experience
- PriorMES experience with Emerson Syncade, Werum PAS-X, or POMSrequired.
- Understanding of Warehouse and Inventory management specificallyand implementation of ERPsystemsin a GMP facility.
- Demonstrated proficiency with experience designing and implementing EBR recipes using GAMP5, S88 and S95 standards.
- Familiarity with cybersecurity compliance and information security in a compartmentalized scientific/technical R+D and business computing environment
- Proficient with MS Word, Excel, PowerPoint, and other MS Office suite applications.
