Biopharma Facilities and Operations Supervisor/Associate
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 open application pool is a continuous, year-long advertisement for those candidates interested in applying to the Supervisor/Associates pool. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates in the pool will be screened.
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
Research Associate I:
- 0-3 years of professional experience
- Bachelor’s degree in the science’s or related field
Research Associate II:
- +3 years of professional experience
- Bachelor’s degree in the science’s or related field
- Master’s degree in the sciences or related field
Research Associate III:
- +5 years professional experience
- Bachelor’s degree in the sciences
- +2 years professional experience
- Master’s degree in the sciences
- PhD in the sciences
Preferred Job Qualifications
- Experience in a contract manufacturing or other regulated environment.
- Has experience in US code of federal regulation fields of GMP,GLP, GXP.
- Biosafetly Level 3 or high containment facility experience.
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 Duty/Responsibility
- 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.
- 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.
- 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.
- Ensure / maintain all assigned equipment areas in a constant state of inspection readiness.
Percentage Of Time 20 Job Duty Category Facilities Duty/Responsibility
- 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.
- Continuously evaluate and critique maintenance practices to eliminate nonproductive activities and implement productivity enhancements.
- Takes responsibility for the management of all assets within BioMARC. 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.
- Interpret and apply best engineering practices to ensure effective preventive and corrective maintenance.
- Ensure all assigned equipment and 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.
Percentage Of Time 60 Job Duty Category Administrative Duty/Responsibility
- Supervise other Facilities & Operations staff members may be required.
- Execute all activities in a timely and concise way.
- Identify training deficiencies, provide recommendations for training and where applicable provide training.
- 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 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.
- Applications will be accepted on a continuous basis. Candidates are likely to be selected prior to the closing date.
- This open pool will expire on 02/01/19 and individuals will need to reapply to any new opening to be considered beyond that date.
References will not be contacted without prior notification of candidates.
Conditions of Employment
Pre-employment Criminal Background Check (required for new hires)
Search Contact BioMARCJobs@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 Title IX Coordinator is the Executive Director of the Office of Support and Safety Assessment, 123 Student Services Building, Fort Collins, CO 80523 -2026, (970) 491-7407.
The Section 504 and ADA Coordinator is the Executive Director of Human Resources and Equal Opportunity, 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.