Facilities Engineer

3 weeks ago

Humble, United States RadioMedix Inc Full time

Job Description

Title:  Facilities Engineer

RadioMedix Inc., a Biotechnology Company headquartered in Houston, Texas, is seeking a mid level Facilities Engineer to work in radiopharmaceutical manufacturing.  The successful candidate will be responsible for the overall facilities and safety needs for both GMP and non GMP areas including Manufacturing, Product Development and Administrative buildings both existing and under design.The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. This is a newly created position with potential for significant growth.

We’re a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape.

To be successful as facilities engineer, you should be able to develop and implement utility plans, perform system evaluations, and establish operational efficiency. A top-notch facilities engineer should have excellent project management skills and strong mechanical knowledge.

Facilities Engineer Responsibilities:

  • Draft, review, execute and perform technical documentation (e.g., development reports, SOPs, protocols & reports, equipment qualifications IQ/OQ/PQ, and validation testing).
  • Schedule validation activities.
  • Execution of IQ,OQ and commissioning of manufacturing suites and manufacturing equipment.
  • Identify deficiencies in manufacturing equipment / processes and design, prototype, and implement improvements or solutions.
  • Perform development and implementation of new equipment technologies e.g. hot cells, QC analytical equipment, refrigerators, freezers, or incubators.
  • Support engineering, comparability, and process validation runs (contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols, and reports for systems that may be complex in nature, to support clinical and commercial manufacturing)
  • Schedule and/or maintain all manufacturing and analytical equipment (e.g., dose calibrators, automated radiochemistry synthesis units, autoclave, ICP-MS, etc.)
  • Schedule and/or maintain facility engineering systems (e.g., HVAC, Pneumatic, Backup Power Generator, and cylinder gas systems, etc.)
  • Communicate with cross-functional teams (e.g. Quality Assurance, Manufacturing, or Operations) any changes to equipment that may result in requalification
  • Works in an ISO-rated cleanroom environment to address equipment deficiencies
  • Maintains, operates, and monitors the equipment (hot cells, manipulators, synthesis modules) used in cGMP production.
  • Review cGMP documentation for accuracy.
  • Routinely originates or revises standard operating procedures (SOPs), risk assessments or preventative maintenance documents related to equipment.
  • Performs process validation activities as needed.
  • Performs activities related to radiation safety processes and radioactive waste management.

Education and Experience:

  • Bachelor of Science (BS) in Mechanical Engineering preferred
  • 3-5 years experience in Facilities Engineering at a Biotechnology Company
  • Primarily at the Humble location but with support at the Richmond (ad hoc basis)

Benefits: Health, Dental & Vision Insurance (effective 1st day of the following month after the start date)

Work Environment:

Location:     Both RadioMedix sites located in Houston and Humble (Primarily Humble location).

9701 Richmond Ave Houston, Texas 77042

19705 Aldine Westfield Rd., Humble, TX 77338

Work Conditions

The work environment consists of manufacturing, laboratory, and office spaces. The position will sometimes require more than forty hours of work per week.  The position is paid as salary. The work period is typically between 8:30 AM to 5 PM.

Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided and radiation monitoring is required and ongoing at the facilities.  Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing themselves, product, or others at risk.

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