Facilities Operations Specialist

2 weeks ago

Camarillo, California, United States PBS Biotech Full time
Job Overview

Company: PBS Biotech, Inc

Department: Manufacturing/Facilities

Position/Title: Senior Facilities Associate

Location: Camarillo, CA

Reporting To: Facilities Manager

FLSA Status: Non-Exempt

Salary Range: $39.47 Hourly

GENERAL PURPOSE

The role is designed to manage administrative tasks for the Blue Mountain Computerized Maintenance Management System (CMMS) while also engaging in hands-on general, mechanical, plumbing, and electrical facility repairs. This position is pivotal in overseeing the daily operations of the CMMS, ensuring that all services are executed and documented promptly.

This role requires close collaboration with members from the Facilities, Quality Assurance, and Engineering Departments, interacting with a diverse range of individuals both within and outside the PBS Biotech Organization.

Key Responsibilities

The essential functions of this role are outlined below. Additional responsibilities may be assigned as necessary. Note that the essential functions may vary based on department size, organizational structure, and/or geographic location. Reasonable accommodations may be made for differently-abled individuals to perform the essential functions of the job.

  • Utilize an automated recall system to align work schedules.
  • Issue monthly calibration recall notifications to various departments.
  • Communicate and coordinate with the department's clientele to schedule work execution and provide updates on outcomes.
  • Oversee and manage both scheduled and emergency work order requests.
  • Coordinate with external contractors providing calibration and facility services.
  • Assist in troubleshooting, maintenance, and calibration of facility and manufacturing equipment.
  • Draft necessary documentation, including certificates and out of tolerance (OOT) notifications.
  • Review calibration certificates issued by external vendors and contractors.
  • Maintain the CMMS database to ensure equipment status and recall data are current.
  • Verify that contractors possess current training to perform GxP activities.
  • Support the Engineering and Facilities departments in acquiring new equipment and entering assets into the CMMS.
  • Conduct asset entry, work plans, work records, reports, and queries in the CMMS.
  • Assist Quality Assurance in non-conformance investigations involving GxP instrumentation and equipment.
  • Perform hands-on general, mechanical, plumbing, and electrical facility repairs.
  • Oversee scheduled and emergency preventive maintenance and work order requests.

Minimum Qualifications

The following qualifications are necessary for an individual to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based on department size and/or geographic location.

Knowledge/Experience

  • 5+ years of experience in hands-on general, mechanical, plumbing, and electrical facility repairs.
  • Experience with Computerized Maintenance Management Systems (CMMS), specifically Blue Mountain, is required.
  • Experience in a pharmaceutical manufacturing environment is preferred.
  • AA degree in information systems or equivalent hands-on experience.

Skills/Abilities Relevant to This Position

  • Proficient in working with automated work recall systems (e.g., CMMS, QMS, LIMS, etc.). Familiarity with Blue Mountain RAM R3/R4 is advantageous.
  • Ability to read and interpret engineering drawings relevant to the trade.
  • Solid understanding of the components associated with an FDA compliant calibration program.
  • Comprehensive knowledge of GxP practices and procedures for instruments related to pharmaceutical processing.
  • Familiarity with cGMP clean room gowning practices and the ability to qualify for room entry.
  • Effective oral and written communication skills in English.
  • Ability to work independently and as part of a team.
  • Strong multitasking abilities with a high degree of self-motivation and integrity.

PHYSICAL DEMANDS

The following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made for differently-abled individuals to perform the essential functions of the job.

Must be able to see, hear, speak, and write clearly to communicate with employees and/or vendors; manual dexterity is required for occasional reaching and lifting of small objects, and operating manufacturing equipment. Must be able to lift various weights as needed to meet job requirements.

WORK ENVIRONMENT

The following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made for differently-abled individuals to perform the essential functions of the job within the environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Typical office setting with laboratory, offices, and cubicles.
  • Manufacturing clean rooms.
  • Equipment/utility areas.

Company Overview

PBS Biotech enhances patient outcomes by offering scalable single-use manufacturing solutions tailored for the cell therapy industry, facilitating broader access to innovative regenerative medicines. The Vertical-Wheel bioreactor provides our clients with a genuinely scalable platform optimized for cell therapy manufacturing needs, streamlining their process development and expediting their time to market.

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