About the Job
Accountable for the development and management of the Site Automation Master Planning, standardizing infrastructure, and strategic leadership to support manufacturing operations, facilities and utilities. Recommend improvements through the use of state-of-the-art computer technology. This position must comply with all Security guidelines. Environment Health and Safety regulations and the current Good Manufacturing Practices (cGMP) required by the job function. Develops and maintains the Site’s Automation Master Plan and provides input on the design of specifications, and/or functional requirements for site equipment and systems. Manages the technical support of process equipment and automation systems; and also supports the Process Equipment Team during process integration of major computer system applications for manufacturing operations, facilities and utilities areas. Leads process equipment analysis and recommends improvements to existing processes through the use of state-of-the-art computer technology and participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology. Leads the installation and configuration of computerized systems in Manufacturing, Facilities and Utilities areas. These systems include (not limited to)\: PLCs, SCADA, DCS, and Fourth generation languages for interfaces and report development. Provides user training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation. Ensures Plant standards are met and that programs are capable of being integrated with other software applications as required. Evaluates workload and capacity of computer systems to determine feasibility for expanding, upgrading or enhancing operations. Evaluates and closes change control documentation assuring the validated and compliance state of the environments. 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. Adheres to data integrity and system security applicable practices under these situations. Assists in the management of Capital Appropriation Requests (CAR’s), budget and timeline of process automation projects and implementation and support Process Automation initiatives. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers. Prepares or provides support in the preparation of system related procedures (e.g., Systems Life Cycle, Operational, Security, System Administration, Backup and Restore and Disaster Recovery) and defines standards for software automation, system integration and defines the strategy for plant automation and process integration through an analysis and design/re-design of current systems and processes. Evaluates and approves Automation services to be provided by all external suppliers, contacts hardware or software vendors to report problems, as required and implements approved vendor recommendations. Keeps abreast with current technology by reading technical journals or manuals and attending to vendor seminars or user forums. Leads changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment or production system. Provide resources to assist in FAT, Commissioning and SAT phases on mfg. system implementations. Reviews and tests programs to ensure that they meet manufacturers recommended requirements for hardware and software at the personal computer and/or host computer system level. Enforces periodic automation network audits and works with Site’s IT, Manufacturing Technology and Engineering Management in the assessment, recommendation, validation, implementation and administration of the Process Automation Systems by providing guidance for determining work procedures, preparation of work schedule, and expediting of workflow. Assists plant and quality assurance management in reviews of computerized systems validation documentation, plans and protocols. Provides technical expertise counsel on issues and concerns regarding validations plans, protocols design and automation during problem resolution activities. Hires, prepares on time Performance Evaluations, takes action for performance improvement, career development and manages Disciplinary Actions in order to have a technically competent and focused customer service oriented team. Maintains a training program in collaboration with the Knowledge Management guidance to assure that direct and indirect report colleagues, and external consultants are adequately trained and certified. Provide supervision and assure that timely and adequate automation systems activities are performed in conformance with cGMP's, plant procedures, corporate policies, and applicable regulations (FDA, EMEA, DEA, etc.).Qualification: BS in Electrical, Mechanical or Computer Engineering. Seven (7) years of experience in process automation in pharmaceutical operations or manufacturing processes with two (2) years of experience in Computer Systems Validation in pharmaceutical environment. Five (5) years of supervision experience. Management & Leadership skills; team oriented leadership. Proficient knowledge of computer system life cycle concepts, change control systems, FDA regulatory requirements, including 21 CFR Part 11 and documentation procedures pertaining to a pharmaceutical manufacturing plant such as cGMP’s, SOP’s, among others. Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications. In-depth knowledge in the design, installation, commissioning and validation/qualification of computerized systems, SCADA, PLC, Data Historian, as applied to pharmaceutical production environment. Experience with external and internal regulatory audits (FDA, EMEA, Otsuka, Sanofi, etc.). Knowledge of mechanical concepts, electrical controls theory and electronic circuitry. Proven skills in systems development and implementation of manufacturing, MES Systems, quality related systems and SAP/R3. Ability to manage and operate computer software packages used for data acquisition systems and PLC programming. Strong Databases and networking knowledge. Able to read, interpret, and understand electrical/mechanical drawings. Good technical writing skills and ability to review SOPs and work instructions. Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data. Excellent oral and written communication skills in both English and Spanish. Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers’ at all organizational levels and disciplines in such a way to facilitate the validation/qualification work. Self-starter and able to plan and prioritize multiple complex activities simultaneously (i.e.\: installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project. Ability to keep work pace and meet deadlines, exercise good judgment and must have problem solving skills. Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.