| Our Culture At Boehringer Ingelheim, we deliver Value through Innovation by living our fundamental principles of Lead & Learn. We have high expectations for our employees. We require employees at all levels of the organization to take initiative, stay connected, grow together, and achieve outstanding results. To enable high performance, we provide opportunities for personal growth, a collaborative and inclusive work environment, and exceptional employee benefits. We reward high achievement with recognition, opportunities and competitive pay. We hold ourselves to the highest standard of excellence and count on each other to go the extra mile in everything we do.
Supervisor, Process Validation
Position Summary: Provides leadership, technical reviews of validation documentation and hands on assistance to direct reports. Prepares and executes validation protocols as needed. Acts as liaison between BVL and customers on validation issues. Duties and Responsibilities:
Provides validation services for customer related projects: Interfaces with customer leads to co-develop or transfer technical processes into BVL. Provides technical assistance in the form of rationales or validation studies to support acceptability of the manufacture of contract products at BVL.
Provides technical assistance to the Validation Department when requested; provides hands on assistance to Process Validation employees. Prepares validation test protocols and performs validation testing.
When requested, participates in CGMP compliance audits initiated by FDA, international governmental agencies and customers.
Provides Production Department with troubleshooting assistance concerning manufacturing anomalies or deviations where product impact may be an issue.
Performs peer review of validation test protocols and reports prepared by subordinates; ensures test protocols and final reports are accurate, reflect validated test conditions and maintain compliance with industry standards and FDA guidance documents.
Maintains area within budget limits
Provides engineering expertise to the Engineering Department related to major facility upgrades.
Requirements:
Requires a Bachelor of Science Degree in Engineering/ Chemistry/ Microbiology or related field.
Minimum of 4 years experience in the pharmaceutical business with hands-on experience writing and executing validation protocols for Products, Cleaning Processes, Media Fills, Equipment, Utilities or Facilities/HVAC systems.
Strong knowledge and understanding of current cGMP regulations and industry standards regarding the validation of aseptic manufacturing processes.
Must possess excellent leadership skills in order to assume responsibility for the training, supervision and discipline of direct report personnel. Excellent analytical skills and be able to prioritize projects, make decisions and determine appropriate courses of action.
Strong communication (both oral and written) and negotiation skills to interface with other organizational areas and/or customers in order to diffuse conflicts and facilitate productive solutions as well as the ability to multi-task and work under pressure and timelines.
Capable of working independently with minimal supervision.
Proficiency in the use of Microsoft Office products including Word, Excel, Access and other software relevant to the performance of the job.
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