• Job Description

  Req#: 16844110
  Job Description:
  
  1. Supports Client's manufacturing facility to ensure that cGMP's related IT Systems are properly maintained in accordance to all Federal, State and Corporate Regulations and therefore, supporting BMS's business goals.
  2. Leads the monitoring and execution management of operational critical systems, like Syncade, Rockwell and others, to assure continuous operations of these computerized systems focused on systems users support. This includes configuration or programming and ongoing maintenance.
  3. Works with the site's Manufacturing, Engineering and Quality Operations Management in the assessment, recommendation, validation, implementation and administration of the Computerized Systems.
  4. Coordinates with Suppliers of hardware/software and services to obtain quotes, ordering parts and repairs.
  5. Developments validation documentation of computerized system (such as validation plans, protocols, procedures, etc.), performs site periodic review of computerized systems validation evaluation and coordinates and performs activities as per approved Validation Plans and Protocols.
  6. Administrates, maintains and executes change control activities related to Quality Systems.
  7. Advises the IT Site Management on the adequacy/completeness of Qualification Protocols for approval.
  8. Generates and maintains the related Standard Operating Procedures and perform required system maintenance activities.
  9. Adminiters on a day-to-day basis the network/systems environment, such as: (1) Add, delete, modify users; (2) add, delete, modify printers and print jobs; (3) verify, create and restore backups; (4) add/remove PCs on the LAN; (5) security administration including granting of file/directory permissions; (6) performance monitoring (7) Database optimization and analysis.
  10. Provides ongoing training to users on procedures, protocols and computer systems.
  11. Works with IT Management and the site's Management in the assessment, recommendation, validation, implementation and administration of the Computerized Systems. Leads IT projects with detailed planning and Time and Event scheduling as well as activity tracking to support Client Operations.
  12. Provides technical advice on the selection of equipment and system software for data acquisition, archival and other quality related systems.
  13. Recommends acceptance of the computer system, as determined from the tests performed on the Protocol and analyzes data in order to determine acceptability.
  14. Recommends actions to be taken if the system is not accepted.
  15. Generates Final/Validation Report in accordance with actual FDA concepts.
  16. Provides assessment, recommendation, implementation, validation, trouble shooting and system administration of computerized systems
  17. Generates and/or executes and recommends action(s) to be taken whenever additions, alterations or changes are to take place in computerized systems.
  18. Provides technical direction on issues and concerns regarding validation plans and Protocol design, provides guidance in the design of specifications and/or functional requirements for computerized systems of Quality Systems.
  19. Installation, configuration, qualification and maintenance of Systems servers including Operating System and Applications.
  20. Performs project management functions for the execution, implementation, commissioning of the new quality systems. Coordinates and executes the installation, maintenance, qualification, validation and upgrade of the new and existing quality systems.
  21. Leads the validation team in the design, development and execution of validation plans and protocols for the systems in scope.
  22. Leads any system related Quality Event Investigation in alignment with corporate directives and Site procedures.
  23. Performs process analysis and recommends improvements to existing processes and participates proactively as a team member of implementation projects for new integrated business application and process automation in equipments such as Building Automation System, Delta V, Factory Talk, SCADA Systems and General PLC's, providing consulting advice in the use and management of technology.
  
  MINIMUM REQUIREMENTS
  • BS in Science, Computer/Information Technology or Engineering
  • Five (5) years of experience in pharmaceutical / manufacturing operations or software development environment
  • Five (5) years of combined experience in process automation or laboratory systems, information systems, and computerized systems validation.
  • Proven project management skills
  • In-depth knowledge of the science and computerized systems involved in the design, installation, commissioning and validation/qualification of computerized systems as applied to pharmaceutical production environment
  • Proficient knowledge of computer system development life cycle concepts, change control systems and FDA and EMEA regulatory requirements, including 21 CFR Part 11
  • Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications
  • Experience with external and internal regulatory audits
  • Knowledge of mechanical concepts, electrical controls theory and electronic circuitry
  • Broad experience in the design, development and implementation of infrastructure, MES and Quality Systems
  • General knowledge in applications such as: Maximo CMMS, TrackWise QMS, DCA DMS, Data Historian and laboratory systems
  • Ability to manage and operate computer software packages used for data acquisition systems and PLC programming
  • Skilled with Microsoft operating systems and MS Office applications
  • Knowledge of Computerized Equipment/Operating Systems: Client Server environment, Windows, Relational Databases: Oracle, SQL, etc.
  • Knowledge of SAP/R3 highly desirable
  • Excellent communication skills (oral, written and reading) in Spanish and English
  • Able to interact effectively with people to establish and maintain excellent working relationships with internal and external customers at all organizational levels and disciplines in such a way to facilitate the assigned work
  • Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary
  • Self-starter and well organized and ability to keep work pace and/or meet deadlines
  • Available to work in the 2nd, 3rd or weekend shifts and willing to work flexible hours, changing shifts (rotational work shifts), nights and weekends as required per business needs based on business needs .
  
  24. Evaluates and closes change control documentation assuring the validated and compliance state of the environments.
  
  *Weil Group is proud to be an Equal Employment Opportunity Employer.*

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