1. Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Production, Facilities and Utilities Areas.
2. Supports all Process Equipment and Process Automation Systems for Production, Facilities and Utilities Areas.
3. Support the Process Equipment team during process integration for major computer system applications that impact the Production, Facilities and Utilities Areas.
4. Assure automated systems operations are maintained considering Plant policies, procedures and FDA regulations under cGMP’s and other regulations applicable.
5. 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.
6. 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.
7. Perform User Access Review for Process Automation Systems
8. Evaluates, generates and closes change control documentation assuring the validated and compliance state of the environments.
9. 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.
10. 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.
11. Prepares and/or reviews system related procedures such as: Operational, Security, Backup and Restore and Disaster Recovery.
12. 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.
13. 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.
14. Provides sound problem solving techniques to resolve issues and qualification problems.
15. Assist in the management of Capital Appropriation Requests (CAR’s), and timeline of process automation projects and implementation and support Process Automation initiatives
Ultimate Solutions Corp is an equal opportunity employer.
- 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.
- Proven skills in projects management, systems development and implementation of manufacturing, MES Systems, and quality related systems.
- Knowledge of SAP/R3 highly desirable.
- Bilingual English/Spanish, both written and verbal are required.
- Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.