Biopharma Facilities & Operations Supervisor/Associate – Open Pool
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Please see Special Instructions for more details.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); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. 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. NOTE 1: Applications will be accepted on a continuous basis. NOTE 2: This open pool will expire 11/30/2017 and individuals will need to reapply to any new opening to be considered beyond that date. How to Apply-please submit application at jobs.colostate.edu. for this position listing. References will not be contacted without prior notification of candidates.
Posting Detail Information
|Working Title||Biopharma Facilities & Operations Supervisor/Associate – Open Pool|
|Research Professional Position||Yes|
|Position Type||Admin Professional/ Research Professional|
|Number of Vacancies|
|Proposed Annual Salary Range||$30,000-90,000|
|Desired Start Date|
|Position End Date (if temporary)|
|Open Posting Date|
|Open Until Filled||No|
|To ensure full consideration, applications must be received by 11:59pm (MT) on|
|Description of Work Unit||
BioMARC is a contract manufacturing organization (CMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CMO owned and operated by CSU,and was created to translate and produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety level 2, 3 and Select Agent biosecurity conditions. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and scalability issues.
This position is open to individuals that have an understanding of engineering concepts and have experience and/or knowledge of a manufacturing environment, preferably biopharmaceuticals. Under the direction of BioMARC’s Facility and Operations Manager, the Facility and Operations Validation Associate is to perform duties in support of GMP compliant facilities and equipment management. It requires escalating levels of experience in project engineering, equipment commissioning and qualification, and equipment maintenance activities. Candidate should have experience working within an FDA recognized Quality System (or similar) using Quality Assurance approved SOPs, protocols and/or the like. A Higher Education degree in mechanical/chemical engineering or related field is strongly suggested. Training in GMP/GLP/GDP and/or Quality Assurance/Control is highly suggested. Candidates must be able to physically work in rooms that require specialized manufacturing and bio-containment protective gowning and equipment. Biosafety level 3 experience is a plus. To be successful in this position, candidates must be able to consistently execute written procedures with precision and efficiency. Moreover, employees must be able to think critically through instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms. Must be able to investigate and report on incidents and provide intelligent corrective proposals.
|Required Job Qualifications||
Bachelor’s Degree in the Sciences, Engineering, Medicine, Business, or Liberal Arts
|Preferred Job Qualifications||
Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
|Job Duty Category||Quality|
• Create/implement/execute written such as User Requirement Specifications, detailed design specifications, equipment commissioning and qualification protocols (IQ/OQ/PQ) reports, SOPs and other directive documents.
|Percentage Of Time||20|
|Job Duty Category||Facilities|
• Perform field verification activities on facility utilities and equipment under the direction of approved testing protocols.
|Percentage Of Time||60|
|Job Duty Category||Administrative|
• Supervise other Facilities & Operations staff members may be required.
|Percentage Of Time||20|
|Special Instructions to Applicants||
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); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. 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.
NOTE 1: Applications will be accepted on a continuous basis.
References will not be contacted without prior notification of candidates.
|Conditions of Employment|
Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. The Office of Equal Opportunity is located in 101 Student Services.
|Background Check Policy Statement||
Colorado State University (CSU) strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks. The type of background check conducted varies by position and can include, but is not limited to, criminal (felony and misdemeanor) history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will be conducted when required by law or contract and when, in the discretion of the university, it is reasonable and prudent to do so.
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