This position is responsible for GMP validation activities at BIVI Kansas and Missouri locations, from concept through process validation as outlined by BIVI's Validation Master Plan (VMP).
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Maintain site validation database and document systems, support feasibility studies, equipment review, selection, acquisition and upgrade.
Develop and maintain standard operating procedures (SOP) and training operations on quality principles.
Support strategic direction of validation philosophies, improve the overall validation system and process flow incorporating into BIVI's VMP.
Support maintenance of Validation department budget, and serve as the [first or second] backup for the Validation Manager when needed.
Support preparation of validation protocols, designing, writing, coordinating, and implementing for facilities, utilities, equipment, systems processes, and cleaning for the Technical Operations Departments, including but not limited to Pharmaceutical and Biological Production, Sterile Filling and Packaging & Labeling.
Support Engineering Department in the selection, review, acquisition, and upgrade of systems and production equipment. Provide technical support in developing user and functional specifications, URS FRS for systems and equipment used in the Technical Operations.
Provide technical problem solving and troubleshooting assistance to all Technical Operations, serving on teams and committees as required.
Train Operations personnel in the design/format of validation protocols,quality principals and the purpose for validation.
Support change control and CAPA initiatives.
Trend and interpret statistical data.
Performs all Company business in accordance with all regulations (e.g.,EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation in the community.
BS degree in appropriate scientific related discipline.
Five (5) years of related experience in the life sciences industry.
Advanced computer skills including microsoft office and software applications
Demonstrate an understanding of data collection and analysis for activities undertaken to verify that cGMP utilities, equipment, and processes are suitable for their intended use.
Ability to communicate verbally and in writing technical reports
Ability to plan, schedule, organize, prioritize, and coordinate project activities
Ability to understand and work within a regulated GMP environment
Ability to use typical validation / data acquisition equipment
Ability to use statistical tools to analyze validation and production data to assess information is within compliance of GMP requirements and troubleshoots trends
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Americas-United States-Missouri-Saint Joseph
Boehringer Ingelheim - 6 months ago