Accountable for leading and supervises automation activities within the Sterile/Non Sterile Manufacturing, Facilities and Utilities areas and; for providing computer technology support to the Computerized Equipment at Production, Facilities and Utilities Areas. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas. Supports all equipment process control and automation systems assuring process control and automation systems operations are maintained considering plant policies, procedures and FDA regulations under cGMP’s and other regulations applicable. Supports process integration for major computer system applications that impact the (Production, Facilities and Utilities) Areas. Performs 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 process automation, providing consulting advice in the use and management of technology. Installs, configures, troubleshoots, and maintains process control and automation systems. These systems include, not limited to: PLCs, SCADAs/HMIs, microcontrollers, single loop controllers, DCS, interfaces and report development. Provides user’s 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 and; also assess and prepares development training in target areas in order to increase technician’s proficiency in current technology and assignments to support reliability program (e.g. FMEA/FMECA documents, root cause analysis, etc.). 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. Evaluates, originates and closes change control documentation assuring the validated and compliance state of the environments and ensures documentation of all maintenance activities is completed using Computer Maintenance Management System (CMMS) and according to procedures. Performs project management functions for the execution, implementation and start-up of new process control and automation systems. Evaluates workload and capacity of process control and automation systems to determine feasibility for expanding, upgrading or enhancing 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. Performs changes to applications, configurations or programming to assure software works as expected before installing it in the user environment. Tests automated systems to determine criticality of component loss prioritizes importance of components and writes recommendations for recovering losses and using backup/restore applicable procedures or methods and; adheres to data integrity and system security applicable practices under these situations. Reads technical journals or manuals and attends vendor seminars or user forums to learn about new process control and automation systems hardware and software systems and, keeps abreast with current technology. Provides project status through the use of project plans and perform best efforts to achieve projects milestones within the pre-established due dates and; provides alternatives and problem solving initiatives during possible project delays or possible showstoppers. Prepares or provides support in the preparation of procedures (e.g., Systems Life Cycle) 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. Prepares and/or reviews process control and automation systems related procedures, such as: Operational, Security, Backup/Restore and Disaster Recovery. Contacts hardware or software vendors (if applicable) to report problems and, coordinates and implements vendor recommendations when approved or accepted by the functional area owners. Assures reported problems are solved by implementing corrective actions like (but not limited) users retraining, changes to existing SOPs, applying software fixes or hardware fixes, information resources colleagues recommendations, etc. These activities must comply with current applicable change control procedures. Provides sound problem solving techniques to resolve issues and qualification problems. Assists in the management of Capital Appropriation Requests (CAR’s), and timeline of process control and automation systems projects and implementation and/or initiatives. Makes sure that Technicians have all the necessary technician tools to support process control and automation systems, such as (not limited to): computer laptops, software, meters, hand tools and communication cables are available and maintained in proper conditions. Supervises the Electro-Mechanic Automation Technicians assigned to Production, Facilities and Utilities Areas (performance appraisals, disciplinary actions, training/development attendance approvals, etc.) and ensures they are skillfully performing the assigned work orders and troubleshooting and are properly documenting it. Assures completion of all process control and automation systems preventive maintenance activities within established frequencies.
BS in Electrical, Computer, Mechanical Engineering, Electronics, or any other Science related field. Five (5) years of experience in pharmaceutical operations or Manufacturing processes. Four (4) years of experience in process control and automation in a pharmaceutical environment. Two (2) years of experience in computerized systems validation. Three (3) years of experience in a supervisory role in a pharmaceutical environment or leading manufacturing teams. Proven knowledge in process control and automation systems used in the pharmaceutical industry (not limited to): PLCs, SCADAs/HMIs, microcontrollers, single loop controllers, DCS, interfaces and report development. Proven project management skills. Proficient knowledge of computer system life cycle concepts, change control systems and FDA regulatory requirements, including 21 CFR Part 11. Proven experience issuing and preparing Computerized Systems Functional Requirements and Design Specifications. In-depth knowledge of the science and physics involved in the design, installation, commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment. Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant. Experience with external and internal regulatory audits (FDA, EMA, Otsuka, Sanofi, etc.). Knowledge of pharmaceutical business processes and equipment. Knowledge of mechanical concepts, electrical controls theory and electronic circuitry. Proven skills in projects management, systems development and implementation of manufacturing, and quality related systems. 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 understands electrical/mechanical drawings, one line diagrams, process flow diagrams and P&IDs. Ability to develop and review SOPs and work instructions. Flexible and responsible. Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data. Bilingual English/Spanish, both written and verbal are required. 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. Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills. Self-starter and well organized. Ability to keep work pace and/or meet deadlines. Ability to exercise good judgment. Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.