Senior IT Mfg System Support & MES Specialist
About the Job
Accountable for providing computerized systems information technology support to the site manufacturing, utilities and facilities systems related to the Manufacturing Execution Systems (MES) environment including the planning, development, implementation and maintenance of these systems pertaining IT areas of scope. Also accountable for project management role for the execution, implementation and start-up of new computerized systems. The incumbent must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job functions. Provides IT expertise support to process equipment, process automation systems for manufacturing operations and to business process teams during process integration for major computer system applications, (e.g., Manufacturing Execution System, PI. synTQ-PAT). Supports Manufacturing Execution Systems and Data Management applications and its related hardware and other System applications such as\: Syncade, OSI PI and SAP Interface. Performs master data set up, system administration and security procedures. Develops the Software/Computers Validations User Requirements, Specifications, Protocols and Validation execution for manufacturing systems applications and recipes. Develops and/or enhances the Syncade recipes and behaviors, to support products manufactured at the site. Recommends acceptance of the computer software, as determined from the tests performed on the Protocol, analyzes data in order to determine acceptability and recommends actions to be taken if the software is not accepted. Analyzes Change Control Procedures and recommend action(s) to be taken whenever additions, alterations or changes are to take place in computerized process. The incumbent recommendations in this matter will be the most reliable source for decision making when these situations arise. Participates proactively as a team member on implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology as well as on how this tools facilities systems integration and/or business requirement. Supports the installation, troubleshooting, maintenance, qualification, validation and upgrade for new and existing computerized systems related to MES environment. Support of the MES applications\: Syncade, OSI PI, SAP Interface, SCADA, DCS systems). Provides training and continuous support to users to assure proper use of the software applications following established operational procedures and users support during problem solving situations associated in new business and/or manufacturing systems implementation. Reviews computer related software applications or computer programs to ensure that Plant standards are met and that programs are capable of being integrated with other software applications as required. Supports the Site Automation group and Manufacturing in evaluating workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing computer operations. Reviews and tests programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Assists in FAT, and SAT phases on mfg system implementations in conjunction with Automaton and Engineering groups related to the MES environment. Tests computer system to determine criticality of component loss prioritizes importance of components and writes recommendations for recovering losses and using backup/restore applicable procedures, adhering to data integrity and system security applicable practices under these situations. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates. Coordinates and implements hardware or software vendor recommendations when approved or accepted by the area manager and; reviews and tests programs to ensure that they meet manufacturers recommended requirements. Provides support to Business and Quality Area applications like\: Maximo CMMS, Kronos Payroll and DCA DMS, among others. Prepares requisition for outside resources to assist in project implementation as needed. Prepares and reviews system related procedures such as\: Operational, Security, Backup and Restore and Disaster Recovery. Assures that reported problems are solved by implementing corrective actions like (but not limited) user retaining, changes to existing SOPs, applying software fixes or hardware fixes, information resources colleagues recommendations, etc. Assists plant and quality assurance management in reviews of computerized systems validation documentation, plans and protocols. Provides technical counsel on issues and concerns regarding validations plans and protocols design. Provides input on the design of specifications, and/or functional requirements for equipment facilities and systems. Provides expertise in the corresponding business and automation during problem resolution activities. Assists Corporate and Plant Quality Assurance in reviewing and auditing vendors of cGMP related software and hardware. Assists critical vendors to attain validable status by advising in modifying their current methodology. Assists Corporate, Plant, and Quality Assurance Management in providing and reviewing computerized systems validation documentation, plans and protocols with federal and local regulatory agencies. Any other task and/or activity deemed necessary according to the site and/or Company needs.Bachelor’s Degree in Science (Chemical, Biology), Computer Science or Engineering (Electrical, Mechanical, Automation or Computer). Minimum five (5) years of experience in computerized systems validation in a pharmaceutical manufacturing operations environment. Two (2) years’ experience deploying and/or supporting Manufacturing Execution Systems (MES). Proficient knowledge of system life cycle concepts, change control systems and FDA regulatory requirements. Proven experience issuing and preparing User/ Requirements, Design Specifications and Other Computer System Validation documentation using standards like GAMP 5, etc. Knowledgeable of Solid Dosage Manufacturing business processes and technologies. In-depth knowledge of the science involved in validation/qualification and integration of computerized systems as applied to pharmaceutical production environment. In-depth knowledge of local/federal regulatory requirements, and documentation procedures (e.g., CGMPs, SOPs, etc.) pertaining to a pharmaceutical manufacturing operation. Proven skills in project management, systems development and implementation of manufacturing and quality related systems. Knowledge of SAP/R3. Ability to manage and operate computer software packages used for data acquisition systems. Knowledge on databases and of different control system network protocols (e.g. Control Net, DeviceNet, Fieldbus, etc.). Excellent oral and written communication skills in both English and Spanish. Good technical writing skills. Able to establish and maintain excellent working relationship with internal and external customers’ at all organizational levels and disciplines in such a way to facilitate validation/qualification activities. Willing to work irregular working shifts (including but not limited to second and third shifts) and/or weekends in-site and/or remotely as deemed necessary, and to be On-call according to pre-determined schedule.