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Sr Facilities Engineer Pharmaceutical

Company: Grimaldi Staffing Services
Location: Fremont
Posted on: August 1, 2022

Job Description:

Sr. Facilities Engineer, GMP (Aseptic, Sterile Manufacturing facility)Job SummaryJoin a successful growing pharmaceutical with a strong legacy as a biotechnology R&D house. This is a full time employment position with excellent benefits. Located near Fremont , California.Relocation is available !
As the company's Sr. Facilities Engineer, you will design, review and implement many construction projects, process engineering, and life cycle cost analysis at the company's modern campus. You will provide engineering support for maintenance, engineering and calibration management programs. You will troubleshoot operations of the process & facilities equipment and utilities. The You will also develop, establishes, and maintain quality-engineering methodologies, systems, and practices which meet internal and regulatory requirements. In this important visible role you will also provide focused quality engineering support for the Facilities department on new construction, facility upgrades/retrofits/modernizations, and facilities equipment.Essential Duties/Responsibilities

  • Perform design review and construction management for projects.
  • Perform in house design and manages facilities engineering and construction projects.
  • Manage the installation and repair of infrastructure of manufacturing and office building.
  • Supports the installation, maintenance, operation, and adjustments made to the HVAC equipment, i.e. pumps, boilers, air handling units, air compressors, cooling towers, and chillers.
  • Collaborate with departments to ensure compliance activities are executed efficiently and effectively, and in accordance with all governing documents and regulatory guidelines.
  • Serve as a subject matter expert (SME) in support of department functions. Develop, mentor, and train personnel and internal customers on relevant business processes.
  • Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards.
  • Track, trend and analyze utility data.
  • Support negotiations and management of technical facility maintenance contracts.
  • Support management and oversight of scheduled preventative maintenance on a wide variety HVAC and electrical equipment.
  • Cross Train in house staff on facilities operation & maintenance.
  • Performs related duties of a similar nature and complexity as required.
  • Liaison between engineering, manufacturing and quality to identifying and resolving quality and compliance related issues
  • Identifies and implements effective commissioning and validation, and support the development, qualification, and on-going quality support of facilities to meet or exceed internal and external requirements
  • Acts as an effective team member in supporting quality disciplines, decisions, and practices.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Assures the development and execution of streamlined quality systems for the team, which effectively identify and resolve quality issuesEducationMinimum Required:
    • B.S. in Related engineering fieldExperienceMinimum Required:
      • HVAC and clean utilities design or installation experience
      • required to occasionally wear personal protective equipment including respiratory protection equipment.
      • Aseptic formulation and filling manufacturing experience required.
      • Ability to work independently and cross-functionally in a dynamic environment.
      • Ability to draft, edit and complete required qualification and engineering documentsKnowledge, Skills and AbilitiesMinimum Required:
        • Must have working knowledge of biological processes, equipment, and facilities. Experience with potent compounds or CDC Select Agent and Toxin regulations a plus.
        • 10-15 years' experience in a GMP regulated environment.
        • Must have exceptional written and oral communication skills.
        • Must be familiar with the Microsoft Office suite of products.

Keywords: Grimaldi Staffing Services, Fremont , Sr Facilities Engineer Pharmaceutical, Professions , Fremont, California

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