Process Automation Specialist / Not less thanThree (3) years of experience
Validation & Engineering Group, Inc
Manatí, Puerto Rico
hace 3 días

Company Description

Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

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 computer 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 computerized systems in Production, Facilities and Utilities Areas. These systems include (not limited to) : , PLCs, SCADA, and Fourth generation languages for interfaces and report development.

Qualifications

  • BS in electrical, computer, mechanical engineering and or related fields.
  • Three (3) 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 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 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.
  • Experinence with external and internal regulatory audits (FDA, EMEA, 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.

    Additional Information

    Positions available for Puerto Rico.

    Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

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