Company Overview Our company specializes in providing Integrated Engineering, Maintenance, Utilities and Specialized Technical Services for the Pharmaceutical, Parenteral, Chemical, & Medical Devices Manufacturing business sectors in compliance with Federal Government Regulations. Qualifications and Skills BS in electrical, computer, mechanical engineering and or related fields. Five-(5) years of experience in pharmaceutical operations or Manufacturing processes with proven project management skills which four (4) of the five years experience, must be in process control and automation in pharmaceutical environment with two (2) years experience in computerized systems validation. 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, MES Systems, and quality related systems. Knowledge of SAP/R3 highly desirable. Ability to manage and operate computer software packages used for data acquisition systems and PLC programming. Strong Databases and networking knowledge's. Able to read, interpret, and understands electrical/mechanical drawings. 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. Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary. Self-starter and well organized. Ability to keep work pace and/or meet deadlines Ability to exercise good judgment Responsibilities and Duties Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas. Supports all Process Equipment and Process Automation Systems for Production, Facilities and Utilities Areas. Support the Process Equipment team during process integration for major computer system applications that impact the Production, Facilities and Utilities Areas. Assure automated systems operations are maintained considering Plant policies, procedures and FDA regulations under cGMP's and other regulations applicable. Perform 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. Installs, configures, troubleshoots, and maintains automated systems in Production, Facilities and Utilities Areas. These systems include (not limited to): PLCs, SCADA, microcontroller, single loop controllers, 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. 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 workload and capacity of automated systems to determine feasibility for expanding, upgrading or enhancing operations. Reviews and test programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Perform changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment. Evaluates, generates and closes change control documentation assuring the validated and compliance state of the environments. Tests automated 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. Read technical journals or manuals and attends vendor seminars or user forums to learn about new automated systems hardware and software. 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 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 system related procedures such as: Operational, Security, Backup and Restore and Disaster Recovery. Contacts hardware or software vendors (if applicable) to report problems. Coordinate and implement vendor recommendations when approved or accepted by the area Supervisors or Manager. Assures reported problems are solved by implementing corrective actions like (but not limited) user 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. Assist in the management of Capital Appropriation Requests (CAR's), and timeline of process automation projects and implementation and support Process Automation initiatives Keeps abreast with current technology. Makes sure all necessary tools to support automated systems, such as computer laptops, software communication cables, are available and maintained in proper conditions. Assess and prepare development training in target areas in order to increase technician's proficiency in current technology and assignments (e.g. FMEA/FMECA documents, RCA (root cause analysis), etc.) Prepares work schedules and match employees with the required skill set for the jobs to be accomplished. Prioritizes the use of resources to most effectively achieve business goals and within budget. Supervises electro mechanics assigned to Production, Facilities and Utilities Areas (performance appraisals, disciplinary actions, training/development attendance approvals, etc.) and ensures they are skillfully performing assigned work orders and troubleshooting and properly documenting it. Ensures documentation of all maintenance activities is completed using Computer Maintenance Management System (CMMS). Associated topics: cultivate, fork lift, garden, inventory, management, mow, plant, production management, scanner, watering
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.