|Working Title||Facilities & Operations Associate I|
|Position Location||Fort Collins, CO|
|Research Professional Position||No|
|Position Type||Admin Professional/ Research Professional|
|Number of Vacancies|
|Proposed Annual Salary Range||30000-55000|
|Desired Start Date|
|Position End Date (if temporary)|
|To ensure full consideration, applications must be received by 11:59pm (MT) on||01/26/2020|
|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.
Under the direction of BioMARC’s Facility and Operations Manager, the Facility and Operations Validation Associate I is to perform duties in support of GMP compliant facilities and equipment management. This position allows for escalating experience in project engineering, equipment commissioning, and qualification, and equipment maintenance activities. Individual will be working within an FDA recognized Quality System (or similar) using Quality Assurance approved SOPs, protocols and/or the like. Training in GMP/GLP/GDP and/or Quality Assurance/Control is inherent with the position. Candidates must be able to physically work in rooms that require specialized manufacturing and bio-containment protective gowning and equipment. Biosafety level 3 laboratory entry is expected. To be successful in this position, individual must be able to consistently execute written procedures with precision and efficiency. Moreover, employee 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 or a field related to the responsibilities of the assignment.
|Preferred Job Qualifications||
• Experience in a contract manufacturing or other regulated environment.
•Personal or professional commitment to diversity and inclusion as demonstrated by persistent effort, active planning, allocation of resources and/or accountability for diversity and inclusion outcomes.
|Job Duty Category||Validation Documentation|
• Create/implement/execute written documents 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||90|
|Job Duty Category||Equipment Maintenance|
• Takes responsibility for the management of all assets in BioMARC. This includes making the right decisions for types of GMP qualification and activities needed to generate GMP grade materials.
|Percentage Of Time||10|
|Special Instructions to Applicants||
To apply, please submit a cover letter which addresses the minimum and preferred qualifications, a resume, and the names and contact information for three professional references. References will not be contacted without prior notification of candidates. References will not be contacted without prior notification of candidates.
|Conditions of Employment||Pre-employment Criminal Background Check (required for new hires)|
|Search Contact||Cathy Griffin (IDRC_Jobs@colostate.edu)|
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.
The Acting Title IX Coordinator is the Assistant Vice President for Student Affairs, 201 Administration Building, Fort Collins, CO. 80523-8004, (970) 491-5312.
The Section 504 and ADA Coordinator is the Associate Vice President for Human Capital, Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.
|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.