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I am a goal-oriented Project Manager and Validation Engineer with extensive experience in generating and executing qualification protocols, writing and implementing SOPs, commissioning mechanical, electrical and plumbing systems, calibrations, mechanical maintenance, team oversight, repairs, monitoring software including equipment monitoring software and building automation systems, training and development, records management, cGMPs, cell culture and aseptic technique. I strive to cultivate strong relationships with clients, vendors, equipment suppliers and contractors while supporting short- and long-term objectives. I also bring strengths in writing and investigating deviations, laboratory design, and environmental monitoring, with a focus on delivering compliant, well-documented results in regulated environments.…I am a goal-oriented Project Manager and Validation Engineer with extensive experience in generating and executing qualification protocols, writing and implementing SOPs, commissioning mechanical, electrical and plumbing systems, calibrations, mechanical maintenance, team oversight, repairs, monitoring software including equipment monitoring software and building automation systems, training and development, records management, cGMPs, cell culture and aseptic technique. I strive to cultivate strong relationships with clients, vendors, equipment suppliers and contractors while supporting short- and long-term objectives. I also bring strengths in writing and investigating deviations, laboratory design, and environmental monitoring, with a focus on delivering compliant, well-documented results in regulated environments.

Brandon Birk

Project Manager, Production Manager, Creative Director, +2

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I am a goal-oriented Project Manager and Validation Engineer with extensive experience in generating and executing qualification protocols, writing and implementing SOPs, commissioning mechanical, electrical and plumbing systems, calibrations, mechanical maintenance, team oversight, repairs, monitoring software including equipment monitoring software and building automation systems, training and development, records management, cGMPs, cell culture and aseptic technique. I strive to cultivate strong relationships with clients, vendors, equipment suppliers and contractors while supporting short- and long-term objectives. I also bring strengths in writing and investigating deviations, laboratory design, and environmental monitoring, with a focus on delivering compliant, well-documented results in regulated environments.…I am a goal-oriented Project Manager and Validation Engineer with extensive experience in generating and executing qualification protocols, writing and implementing SOPs, commissioning mechanical, electrical and plumbing systems, calibrations, mechanical maintenance, team oversight, repairs, monitoring software including equipment monitoring software and building automation systems, training and development, records management, cGMPs, cell culture and aseptic technique. I strive to cultivate strong relationships with clients, vendors, equipment suppliers and contractors while supporting short- and long-term objectives. I also bring strengths in writing and investigating deviations, laboratory design, and environmental monitoring, with a focus on delivering compliant, well-documented results in regulated environments.

Available to hire

I am a goal-oriented Project Manager and Validation Engineer with extensive experience in generating and executing qualification protocols, writing and implementing SOPs, commissioning mechanical, electrical and plumbing systems, calibrations, mechanical maintenance, team oversight, repairs, monitoring software including equipment monitoring software and building automation systems, training and development, records management, cGMPs, cell culture and aseptic technique.

I strive to cultivate strong relationships with clients, vendors, equipment suppliers and contractors while supporting short- and long-term objectives. I also bring strengths in writing and investigating deviations, laboratory design, and environmental monitoring, with a focus on delivering compliant, well-documented results in regulated environments.

Skills

Experience Level

Expert

Expert

Expert

Expert

Intermediate

Language

English

Fluent

Work Experience

Validation Engineer at Clarus Validation Group LLC

January 1, 2018 - May 30, 2023

Generation and execution of qualification protocols including cleaning validation and equipment validation protocols. Writing and implementing SOPs across equipment, quality systems, facilities and maintenance. Writing and implementing maintenance procedures including calibration and preventative maintenance records. Analyzing and assessing suitability of systems and equipment for user requirements and needs.

Commissioning Agent at Cornerstone Commissioning Inc.

January 1, 2016 - January 1, 2018

Oversee/assist commissioning efforts for mechanical electrical and plumbing systems in the Midwest in a wide variety of buildings including University Buildings, University Laboratories, BSL3 Laboratories, FDA regulated facilities with cleanrooms. Job duties included project management of commissioning projects, commissioning documentation writing, pre-functional checks of equipment, functional performance testing of equipment, integrated system testing of equipment, training of owner staff in all commissioned systems.

Supervisor, Facilities and Equipment at NewLink Genetics

January 1, 2016 - Present

Oversaw writing and execution of all equipment qualification protocols and equipment SOPs. Directed maintenance, calibration and repairs on various types of lab equipment. Supervised 2 engineering student interns and 1 cleaning and maintenance associate. Wrote and investigated deviations and CAPAs. Coordinated with outside vendors to complete various tasks. Wrote requisitions / purchase orders and helped maintain department budget.

Specialist, Facilities and Equipment at NewLink Genetics

January 1, 2013 - January 1, 2015

Wrote and executed equipment qualification protocols, as well as equipment SOPs. Performed maintenance and calibration on various types of lab equipment. Supervised 2 engineering student interns and 3 cleaning associates. Maintained and repaired over 100 pieces of equipment throughout company. Completed trainings including Torque Machine, Faciliworks computer maintenance management software, Amega monitoring software, Metasys HVAC monitoring system, and 5S. Participated in introduction to ControlLogix and RSLogix 5000, as well as training in investigations and CAPAs.

Supervisor, Manufacturing at NEWLINK GENETICS

January 1, 2012 - January 1, 2013

Directed team's production of Hyper Acute Immunotherapy platform of drugs. Wrote appropriate SOPs, as well as review and edit batch production records. Ensured team followed SOPs. Scheduled responsibilities for the production of lots. Ensured cleaning and environmental monitoring was completed in accordance with SOPs and guidelines. Ensured proper aseptic/laboratory technique was used during production. Planned, designed and executed process characterization experiments. Coordinated with other departments for service on facility, equipment, and Quality Control testing.

Research Associate I, II, and III, Manufacturing at NEWLINK GENETICS

January 1, 2008 - January 1, 2012

Performed cell culture and lab work. Produced company’s Hyper Acute immunotherapy platform of drugs. Wrote and edited SOPs. Reviewed and edited batch production records. Provided environmental monitoring. Cleaned ISO 7 and ISO 8 areas. Completed successful training on Nova BioProfile FLEX analyzer.