Facilities & Operations Associate I

Updated: 5 months ago
Location: Fort Collins, COLORADO

Posting Details

Posting Detail Information

Working Title Facilities & Operations Associate I
Position Location Fort Collins, CO
Research Professional Position No
Posting Number 202000023AP
Position Type Admin Professional/ Research Professional
Number of Vacancies
Work Hours/Week 40
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.

Position Summary

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.
• OR Bachelor’s degree in an unrelated field plus 2 years of professional experience related to the specific assignment
• OR Bachelor’s degree in an unrelated field plus 1 year experience in a contract manufacturing organization.

Preferred Job Qualifications

• Experience in a contract manufacturing or other regulated environment.
• Has experience in US code of federal regulation fields of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP).
• Biosafety Level 3 experience/ or high containment facility.
• Experience in a microbiology or cell biology type laboratory.

Diversity Statement

•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.

Essential Duties

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.
• Perform field verification activities on facility utilities and equipment under the direction of approved testing protocols.
• Independently analyze complex equipment performance data sets, summarize findings, perform risk analysis, and chart corrective actions. Must consistently exercise discretion and judgment to meet production standards in GMP environment.
• Complete sophisticated documentation requirements for all GMP activities following Good Documentation Practices (GDP). Must be able to justify all written records to Regulatory Auditors (e.g., FDA) in person.
• Support the clean room maintenance of the production and support rooms. This involves the physical movement or selected equipment according to best practices for GMP and safety.
• Supervise other Facilities & Operations staff members may be required.
• Continuously evaluate all associated Standard Operating Procedures, engineering drawings, and various other controlled documentation for accuracy and applicability, and make improvements based on best practices.
• Continuously evaluate and critique maintenance practices to eliminate nonproductive activities and implement productivity enhancements.

Percentage Of Time 90
Essential Duties

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.
• Execute all activities in a timely and concise manner.
• Interpret and apply best engineering practices to ensure effective preventive and corrective maintenance.
• Ensure all assigned equipment are maintained in the following manner: All Preventative maintenance is performed at the appropriate interval and is completed by the assigned due date. All equipment remains in its designed and/or validated state at all times. All equipment operation is in accordance with Federal, State, Local and BioMARC regulations, procedures, and policies. Complete preventive maintenance and assigned paperwork in a safe and timely manner following all cGMP documentation guidelines.
• Coordinate and instruct contractors/vendors who perform repairs, modifications, and installations of various equipment.
• Work directly with BioMARC’s Manufacturing, Quality organizations on new system installations or modifications and maximize equipment availability.
• Perform other duties as required.

Percentage Of Time 10

Application Details

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)
EEO Statement

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.

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