Senior Manager of Engineering

11/21/22

San Antonio, TX

1863

1863- Senior Manager of Engineering

Senior Manager of Engineering is responsible to ensure that the manufacturing equipment/systems used in the production, storage, testing and distribution of products are fit for purpose in accordance with company standards and industry regulatory requirements.

The Process Engineer will be responsible for the design, purchasing, installation, troubleshooting, qualification, operation and maintenance of process equipment and systems including, but not limited to, manufacturing equipment such as:

  • Aseptic Filling
  • Cleaning System (i.e COP (Clean out of Place), CIP (Clean in Place))
  • Decontamination System (i.e VHP ( Vapor hydrogen peroxide)
  • Sterilization System ( SIP (Sterilization in Place), Autoclave (Steam Sterilization))
  • Clean Room Environment (ISO 5, ISO 8 AND ISO 9)

Responsibilities

  • Develop, evaluate and implement cost-effective engineering equipment design solutions for a manufacturing facility in a fast-paced cGMP, biotechnology environment.
  • Work independently with some to limited supervision.
  • Define and implement projects. Define scope, cost, justification and benefit of projects.
  • Own and implement change control documentation and projects. Drive projects to completion to meet timeline and budget objectives.
  • Create and maintain specifications (Design/Functional/System) and drawings New Package Introduction
  • (P&ID/Layout/etc)
  • Perform factory and site acceptance tests (FAT/SAT), installation, commissioning, debugging, and optimization.
  • Support Validation scope definition, development and execution.
  • Technical Lead for a cross functional team for implementation of projects.
  • Create and update written Standard Operating Procedures (SOPs) related to project assignments. Train maintenance and manufacturing personnel.
  • Provide technical support for equipment in manufacturing, as second level support. Act as the subject matter expert (SME) of equipment.
  • Assist/Lead in Quality and Safety investigations

Education and Experience Requirements

  • Bachelor's degree in Engineering discipline required. 8+years of process development/project management experience in an aseptic pharmaceutical facility. Some leadership experience preferred for supervisory roles.

Key Skills, Abilities, and Competencies

  • Must have a demonstrated track record of successfully executing engineering projects, and supporting facility issues, in a FDA-regulated manufacturing environment.
  • Possess knowledge of core principles in various engineering disciplines including manufacturing (i.e. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design.
  • Possess knowledge on manufacturing process as follows:
  • Aseptic Filling
  • Cleaning System (i.e COP (Clean out of Place), CIP (Clean in Place))
  • Decontamination System (i.e VHP ( Vapor hydrogen peroxide)
  • Sterilization System ( SIP (Sterilization in Place), Autoclave (Steam Sterilization))
  • Possess Knowledge in Clean Room Environment (ISO 5, ISO 8 AND ISO 9)
  • Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
  • Must have the ability to effectively participate in Engineering projects and drive results.
  • Direct experience with manufacturing operations and pharmaceutical processes is strongly preferred.
  • Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.), as well as be experienced applying project management methodology.
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
  • Knowledge of programmable logic controllers, DCS, instrumentation and controls highly desirable.
  • Has the ability to prioritize multiple tasks and work on multiple projects simultaneously.
  • Must be a self-starter, detail oriented and able to work independently.
  • Must embrace working in a fast-paced, team-oriented, cross-functional environment.
  • Desire Experience with Optima Filling Equipment and Steris Steam Sterilizer

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