Christopher Vales Email & Phone Number

New York, Ny, Us

Thousand Oaks, Ca, Us

Allendale, Nj, Us

Allendale, Nj, Us

Thousand Oaks, Ca, Us

Provide IS and Automation leadership, expertise, and support for a bulk bio-pharmaceutical manufacturing facility. Collaborate with cross-functional teams in the safe execution of new product introductions and commissioning/qualification activities. Provide expertise/leadership in the development/execution of qualifications. System Owner responsible for compliance and performance throughout the system life-cycle. Change Owner responsible all aspects of system modification and qualification. NC/CAPA Owner responsible timely and compliant resolution of abnormal events. Provide technical knowledge and participate in risk based assessments and audits. Lead and implement projects using both COTS and custom solutions into cGMP manufacturing environments.Current Roles:Project Manager for Pilot Plant process control system redesign(DeltaV).Automation Intern Manager/Mentor for 2013 and 2014.Automation lead for Process Engineering and Digital Development Laboratories(PAT lab). Recent Accomplishments:Bench-top Glucose Control -Integrated Kaiser Raman Spectral analyzer probe into a closed loop control scheme. -Developed supervisory glucose addition in DeltaV with Sartorius BioreactorControl System Audit Trail redesign -Lead the development of User and Functional requirements. -Mitigated known compliance risks. -First qualified reports in OIM (SAP Business Objects) on site.Automated Recipe Validation -Designed/implemented XML/XLS application to compare specifications to configuration. -Complete elimination of non-value and error prone manual verification. -$833K NPV after 2 years.Analytics Engine for Transition Analysis -Technical solution architect. -Extendable calculation engine utilizing MATLAB and OSI PISystems Ownership:Manufacturing Batch Reporting, PI Data Historian, Logmate Alarm and Event HistorianAwards: AR5 Yield Improvement ProjectReal-Time Multivariate Statistical Process Monitoring in cGMP manufacturing

Participate in automation activities in support of a viral vaccine manufacturing facility. Responsible for the development of qualification, SOP and PM documentation, as well as reports, data and information to support on-going operations and ensure cGMP compliance.Integrated tablet PC base analytical instruments for viability cell counts. Utilized wireless network infrastructure for the management and data archiving. Design/implemented tool set for remote management/administration tasks. Design/implemented data archiving program to allow automatic, on-demand, and remote data archive of data.Manage/Maintain/Modify Informetric’s InfoBatch reporting tool.Exceptional understanding of DeltaV Batch historian. Developed data archival to oracle utilizing existing database architecture/scripting. Optimized the database to increase client applications performance.Manage/Maintain/Modify an Oracle based alert management database that utilizes real-time data to alert end-users of process alarms and events. Create/modify query sets for aggregating alarms and events data per operations requirements.Managed the development and launch of a web base work order request system. Interfaced with customers to define requirements and goals. Defined the systems requirements through presentations and formal documentation. Assisted in the development of the Oracle based back-end.

Rahway, New Jersey, Us

Lestrem, Hauts-De-France, Fr

Responsible for management and maintenance of plant wide data historian application servers. Improved system architecture and performance thru component upgrades. Developed reporting for management/engineering/production personnel that aggregated and maintained KPI’s. Work with end users to determine and define business application needs.

Bedford, Ma, Us

Lead projects from inception to completion utilizing project management and technical skill sets. Developed the business by providing customer presentations, prototyping, technical solutions expertise and proposal writing.Specified, designed, implemented, and tested/validated Aspen Technology’s Manufacturing Suite in the Specialty Chemical and Life Science vertical markets. Extensive SQL query writing for data historian (InfoPlus.21) and MS SQL Server integrations and custom application.Designed/Implemented a SQL Server Database to process material usage transactions from DCS to PRISM (MRP).Design/Implementation of SQL Server Database for ETL integration of MESA and MAPICS with AspenTech’s MIMI Global Planner(Forecasting and demand management application) for a chip fabrication facility.

Royersford, Pennsylvania, Us

Performed design, implementation, and testing on manufacturing control systems (Provox, Intellution, PLC). Provided cGMP Pharmaceutical manufacturing startup and commissioning services.Designed and implemented reporting applications using MS SQL and Crystal Reports to provide customers with KPI's, plant dashboards and regulatory reports(EPA, FDA).ETL data integration of batch manufacturing control system with plant Material Resource Planning (MRP) system. Utilized continuos data historian (Infoplus.21) and MS SQL Server to aggregate material usage/production data from the control system into the MRP system.Designed and implemented small scale Laboratory Information Management System(LIMS) using MS SQL server and Access.