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WHAT
IN
Manager Quality Engineering
Job
Boehringer Ingelheim
US
-
Bedford,
Ohio
Job Code - BV29109
Position - Full Time
Job First Active on: Sunday, November 01, 2009
APPLY TO THIS JOB (You will be applying directly to Boehringer Ingelheim for this position!)
JOB DESCRIPTION: Manager Quality Engineering
Boehringer Ingelheim is currently seeking a talented and innovative Manager, QA Engineering/Validation to join our Quality Assurance department in Bedford, OH location. As a Manager, QA Engineering/Validation, you will direct and supervise Quality Engineering and Validation operations in the Quality Assurance department. This position oversees the engineering related projects and applies quality oversight to the design and operation of facilities, equipment and processes. The position also includes oversight of the QA validation process which ensures that validation activities and documentation are compliant with internal/external requirements including cGMPs. This role is responsible for maintaining open communication with the Director of Quality Operations at Ben Venue Laboratories as well as with Operations management and the employees within department.
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.
Responsibilities:
* Insures compliance with current cGMP regulations and industry standards regarding the validation of aseptic manufacturing processes and associated support systems (e.g. computer, facility, equipment, sterilization, cleaning, etc.).
* Guides a staff to provide timely resolution of Quality issues discovered during operation of the facility or the manufacturing of both Bedford and Contract products. This requires working with Engineering, Maintenance and the Production management areas for real-time identification of the root cause(s), impact assessment, and development of resolution strategies which may implement appropriate immediate corrective actions in addition to longer term remediation activities. The Manager determines if identified issues require product segregation and/or evaluation for quality, safety, purity, or efficacy.
* Responsible for resolving any identified quality issues during the design, construction or implementation of systems or processes prior to approval and release for cGMP manufacturing.
* Reviews and approves or provides oversight to the QA Validation staff relative to the review of validation related documents. Ensures that validation philosophies and approaches are reflective of current GMPs and other regulatory requirements. Also ensures that validation activities are aligned, where applicable, to corporate and internal requirements.
Requirements:
* Requires a four year college degree preferably in an engineering related field.
* Minimum of 7 years pharmaceutical industry experience in quality assurance with a strong validation engineering background.
* Minimum of 3 years supervisory experience in a pharmaceutical environment.
* Must be able to fully understand and comply with the current good manufacturing practices (cGMPs) as specified in the CFR’s and USP/& EP Pharmacopoeia.
* Must remain current in industry standards and best practices through seminar training and literature review.
Strong communication skills, both oral and written
* Efficiency in Microsoft Office, including Word and Excel
REQUIREMENTS - QUALIFICATIONS: Manager Quality Engineering
See information above.
Boehringer Ingelheim, Ltd.
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