This open application pool is a continuous, open-ended advertisement for those candidates interested in applying to one of the job titles listed below. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates with documents in the pool will be screened preferentially. Additional information about the applicant pool and how to apply are listed at the end of this document. The jobs covered in this pool include: LS0030 – Facilities, Operations and Validation Technician/Manager
Job description of the Facilities, Operations and Validation Technician/Manager position:
This position requires strong knowledge of engineering, facility maintenance, laboratory equipment and experience in biotech or pharmaceutical setting. Preferred experience with manufacturing and knowledge of cGMP quality requirements for FDA regulated products. Under the direction of the Director, this position is responsible for: • Maintaining and repairing equipment and communicating with technical experts to ensure proper function of equipment and efficient operation of facility. • Management of complex systems and large numbers of instruments and equipment. Strict adherence to timelines, management of routine maintenance, equipment installation, operation, and performance qualification. • Being on call and setting up a response team for equipment malfunction and maintenance. • Supervise the procurement and use of all of BioMARC’s equipment. • Responsible for the conforming calibration, qualification and validation status of equipment. • Responsible for supervising the coordination of facility support. • Performs cyclical preventative maintenance on all of BioMARC’s equipment. • Supports a controlled database for the documentation and trending of the performance readings (i.e., temperature readings, pressure readings, etc.) for critical equipment. • Creates equipment protocols, reports, SOPs and other directive documents. • Performs investigations, root cause analysis , and CAPAs related to equipment and system issues. • Proactively communicates equipment status to affected departments during qualification, routine maintenance or unplanned maintenance of equipment Additional experience: • Experience with building commissioning and validation preferred. • Experience with building automation systems preferred.
Candidates must show attention to detail, have excellent communication skills and be able to work within a team under challenging and sometimes stressful conditions. Candidates should have strong time management and organizational abilities. Experience in a cGMP setting is highly advantageous. Candidates must be comfortable entering Clean Room and High Containment laboratories that require specialized personal protective equipment (gowning, tyveks suits, gloves, etc.).
Candidates must have above average communication skills (writing and speaking) and be responsible for supporting a healthy working environment between other departments and facility staff. May oversee personnel engaged in FO & V support activities. Perform other assigned duties as necessary. Compensation and level of responsibilities is dependent on job-specific education, training, and experience. Requires an Associate’s or Bachelor’s degree.
Employment Type: The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort). Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds and one’s skill set. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables.
Applicatin Deadline: 7-15-2013. NOTE: This pool will expire in approximately one year (7-15-2014) and individuals will need to reapply to be considered beyond that date.
How to Apply to the Bio/Pharmaceutical Facilities, Operations and Validation Technician/Manager Applicant Pool: Email in PDF form a cover letter addressing your ability to meet the required and desired professional attributes, provide a job specific resume to: FOVBioMARC@colostate.edu
Applications will be accepted on a continuous basis.
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