Colorado State University Facility and Operations Associates I or II - Open Pool in Fort Collins, Colorado
Working Title Facility and Operations Associates I or II - Open Pool
Position Location Fort Collins, CO
Research Professional Position Yes
Posting Number 202000771AP
Position Type Admin Professional/ Research Professional
Number of Vacancies
Proposed Annual Salary Range $30,000 - $60,000 Salary is commensurate with experience and qualifications
Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by 11:59pm (MT) on 03/31/2021
Description of Work Unit
BioMARC is a contract development and manufacturing organization (CDMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CDMO 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.
The Facility and Operations Associates are responsible for the implementation of policies, practices, and procedures to ensure that qualified fit for use assets and facilities are available for use in the preparation of cGMP biological material. The positions require escalating levels of experience in project engineering, equipment commissioning and qualification, and equipment maintenance activities. Individuals will be working within an FDA-recognized Quality System (or similar) using Quality Assurance approved SOPs, protocols and/or similar controlled documents. Candidates must be able to physically work in rooms that require specialized manufacturing and bio-containment protective gowning and equipment as Biosafety level 3 laboratory entry is expected. In addition to cGMP work, equipment and facility management in support of Non-Clinical production/research support may be assigned with the expectations that the employee make use of skills similar to those described above.
Required Job Qualifications
• Applicants must have a Bachelor’s degree in Engineering, biotechnology or a closely related field. Required qualification, rank and salary determined by specific position to be filled. • Minimum Qualifications: o Level I is for individuals with a Bachelor’s degree and less than 3 years of relevant professional experience OR Bachelor’s degree in an unrelated field plus 2 years of professional experience related to the specific assignment or 1 year experience in a contract manufacturing organization. o Level II is for individuals with a Bachelor’s degree and 3 or more years of relevant professional experience OR a Master’s degree with no experience OR Bachelor’s degree in an unrelated field plus 5 years of professional experience related to the specific assignment or 4 years’ experience in a contract manufacturing organization • Successful candidate must be legally authorized to work in the United States at time of application; IDRC/BioMARC will not provide visa sponsorship for these positions.
Preferred Job Qualifications
• Experience in a contract manufacturing or other regulated environment. • Experience in maintenance or validation of equipment in a regulated environment • Experience in US code of federal regulation fields of GMP, GLP, GXP. • Biosafety Level 3 experience or high containment facility. • One-year of work experience is also preferred.
Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
Special Instructions to Applicants
Please submit a cover letter outlining your specific area(s) of expertise, curriculum vitae and the names and contact information of three professionals references.
References will not be contacted without prior notifications of candidates.
The pool is valid through 3/31/2021. Individuals wishing to be considered beyond this date must reapply.
Conditions of Employment Pre-employment Criminal Background Check (required for new hires)
Search Contact Darragh Heaslip, Darragh.Heaslip@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 Vice President for Equity, Equal Opportunity, and Title IX, 123 Student Services Building, Fort Collins, CO. 80523, (970) 491-1715.
The Section 504 and ADA Coordinator is the Vice President for Equity, Equal Opportunity, and Title IX, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.
Background Check Policy Statement
Colorado State University 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 history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.
Minimum Requested 3
Maximum Requested 3
Required fields are indicated with an asterisk (*).