- Work with an automated recall system to reconcile work schedules.
- Supply monthly calibration recall notices to Departments.
- Communicate and coordinate with the Department's customer base for the purpose of scheduling work execution and updating them on the outcome.
- Coordinate and/ or oversee scheduled and emergency work order requests.
- Coordinate and/ or oversee outside contractors providing calibration and facilities services.
- Support trouble shooting, maintenance, and calibration for facility and manufacturing equipment.
- Write necessary documentation, including certificates and out of tolerance (OOT) notifications.
- Review calibration certificates performed by outside vendors and contractors.
- Update the CMMS database to keep equipment status and recall data current.
- Assure contractors have current training to perform GxP activities.
- Assist the Engineering and Facilities departments in new equipment acquisition and asset entry in CMMS.
- Perform asset entry, work plans, work records, reports, and queries in CMMS.
- Assist QA in non-conformance investigations where GxP instrumentation and equipment is involved.
- Perform hands on general, mechanical, plumbing, and electrical facilities repairs.
- Oversee scheduled and emergency PM's and work order requests.
- 5+ years' experience with hands-on general, mechanical, plumbing, and electrical facilities repairs.
- Experience working with Computerized Maintenance Management Systems (CMMS), specifically Blue Mountain, is required.
- Experience working within a pharmaceutical manufacturing environment preferred.
- AA degree in information systems or equivalent hands-on experience.
- Ability to work with automated work recall systems (e.g., CMMS, QMS, LIMS, etc.). Experience with Blue Mountain RAM R3/ R4 is a plus.
- Ability to read and interpret engineering drawings relevant to the trade.
- Possess a sound knowledge of what aspects are 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 English communication skills.
- Ability to work both independently and as a contributor to a team.
- Ability to multi-task with a high degree of self-motivation and good ethics.
- Typical office setting with a laboratory, offices, and cubicles.
- Manufacturing clean rooms.
- Equipment/ utility areas.
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Senior Facilities Associate - Camarillo, United States - PBS Biotech
Description
Job Description
Job DescriptionCompany: 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 purpose of the position is to perform administration for the Blue Mountain Computerized Maintenance Management System (CMMS) and also perform hands on general, mechanical, plumbing, and electrical facilities repairs. This position is responsible for overseeing daily operations of the CMMS and ensuring all services are performed and documented in a timely manner.
This position works closely with all members of the Facilities, QA, and Engineering Departments. This position interacts with a broad base of individuals and personalities both within and external to the PBS Biotech Organization.
Responsibilities
Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
Primary Responsibilities
Minimum Qualifications
The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
Knowledge/ Experience
Skills/ Abilities Pertinent to This Position
PHYSICAL DEMANDS
In general, 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 to allow differently-abled individuals to perform the essential functions of the job.
Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity 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
In general, 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 to allow 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
