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Colorado State University Facilities & Validation Technical Manager in Fort Collins, Colorado

Working Title Facilities & Validation Technical Manager

Position Location Fort Collins, CO

Research Professional Position No

Posting Number 202000032AP

Position Type Admin Professional/ Research Professional

Classification Title Prof/Indiv Contrib III

Number of Vacancies

Work Hours/Week 40

Proposed Annual Salary Range $96,000 - $120,000

Desired Start Date

Position End Date (if temporary)

To ensure full consideration, applications must be received by 11:59pm (MT) on 02/03/2020

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 bio-pharmaceutical products for non-clinical, clinical, and commercial use under Biosafety level 2, 3 and Select Agent bio-security 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

The Facilities and Validation Technical Manager is responsible for managing the procurement, installation, commissioning, qualification, and use of all BioMARC’s production and analytical equipment. The perfect candidate will have knowledge in managing equipment records and IOP qualifications for manufacturing related equipment in an FDA regulated environment. Requires expertise in project engineering, equipment commissioning and qualification, preventative and corrective maintenance activities, and instrument calibration. The successful candidate will need expertise in GMP (good manufacturing practice) concepts, practices, and procedures. The ideal candidate will also have the ability to proactively manage equipment and facility-related concerns, including being able to make minor mechanical repairs, be able to work in BSL-3, think critically and make professional judgements with regard to personnel management, compliance, quality, and continuous improvement paradigms. Additionally, candidates will ideally be able to clearly and efficiently communicate with others, investigate and report on incidents and provide intelligent corrective proposals, and report job outcomes in a timely manner to Directors and clients.

Required Job Qualifications

  • Bachelor’s degree in Engineering or related field OR Bachelor’s degree in an unrelated field with 5 years of relevant work experience.

  • 5 years of experience in a supervisory role of a Mechanical or related engineering group.

  • 5 years of experience in the pharmaceutical industry

  • Experience in project engineering, equipment commissioning and qualification, preventative and corrective maintenance activities and instrumental calibration.

  • Expertise in GMP (good manufacturing practice) concepts, practices, and procedures.

  • Ability to obtain U.S. Government security clearances and Homeland Security CDC Select Agent Tier I clearance.

Preferred Job Qualifications

  • Experience in a contract manufacturing, pharmaceutical, or other regulated environment.

  • 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 experience in a high containment facility

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 Laboratory, GMP Production Facility and Equipment Maintenance, Management and Coordination

Duty/Responsibility

• Creation and oversight of complex equipment management systems and large numbers of instruments and equipment. Independently establish polices that support work efforts and lead to strict adherence to timelines, management of routine maintenance, instrument calibration, equipment commissioning, equipment installation, operation, and performance qualification. • Responsible for supervising the coordination of non-BioMARC facility support. • Oversees activities (and may perform) cyclical preventative maintenance on all of BioMARC’s equipment. • 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. • Supervise all other Facilities and Operations team members including Facilities and Operations Supervisor, Associate and Student positions. • Continuously evaluate all associated Standard Operating Procedures, engineering specification, and various other controlled documentation for accuracy and applicability, and make improvements based on best practices. • Continuously evaluate and critique operations activities to eliminate nonproductive activities and implement productivity enhancements. • Takes responsibility for the management of all assets within BioMARC. • Interpret and apply best engineering practices in cooperation with a flexible approach to project requirements • Ensure all assigned equipment is maintained in the following manner: o All Preventative maintenance and instrument calibrations are performed at the appropriate interval and are completed by the assigned due date. o All equipment remains in its designed and/or validated state at all times. o All equipment operation is in accordance with Federal, State, Local and BioMARC regulations, procedures, and policies. o Complete all production-related activities 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 Process Development, Manufacturing, and Quality departments on new system installations or modifications and maximize equipment availability.

Percentage Of Time 50

Job Duty Category Laboratory, Database, and Process Compliance

Duty/Responsibility

• Responsible for the operational readiness, calibration, qualification and validation status of equipment. • Establishes and/or maintains a controlled database for the documentation, trending and analysis of the performance readings (i.e., temperature readings, pressure readings, etc.) for critical equipment. • 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. • Completes 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. • Ensure/maintain all assigned equipment areas in a constant state of inspection readiness.

Percentage Of Time 35

Job Duty Category Documentation, and Team Coordination and Communication

Duty/Responsibility

• Primary point of contract for BioMARC’s GMP facility and operations department. • Provide assignment guidance and coordination to Facility and Operations team to ensure proper function and readiness for BioMARC equipment and facilities. • Maintains and repairs equipment and communicates with technical experts to ensure proper function of equipment and efficient operation of facility. • Be on call and set up a response team for equipment malfunction and maintenance. • Provide expert knowledge on the procurement and installation of all of BioMARC’s equipment. • Create equipment protocols, reports, SOPs and other directive documents. • Independently performs investigations, root cause analyses, and CAPAs related to facilities, equipment, and systems issues. • Proactively communicate equipment status to affected departments during commissioning, qualification, routine maintenance or unplanned maintenance of equipment, and instrument calibration • Perform field verification activities on facility utilities and equipment under the direction of approved testing protocols. • Support the clean room maintenance of the production and support rooms. This involves the physical movement of selected equipment according to best practices for GMP and safety. • Execute all activities in a timely and concise way. • Identify training deficiencies, provide recommendations for training and where applicable provide training. • Perform other duties as required

Percentage Of Time 15

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 of three professional references. 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.

References Requested

Minimum Requested 3

Maximum Requested 3

Supplemental Questions

Required fields are indicated with an asterisk (*).

Applicant Documents

Required Documents

  • Cover Letter

  • Resume

Optional Documents

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