| 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.
Manager, Process Validation
Position Summary: Directs the work of process validation staff and provides them with leadership and mentoring. Ensures validation activities are compliant, efficient and cost effective. Acts as liason between BVL and customers on validation issues. Duties and Responsibilities:
Insures compliance with current cGMP regulations and industry standards regarding the validation of aseptic manufacturing and sterilization processes.
Leadership/managerial responsibilities for direct reports: examples include, provide leadership to subordinates by directing, mentoring, coaching and developing them towards personal growth, enhanced job performance and career satisfaction.
Ensure BVL's operation meets the regulatory standards required by FDA, EMEA, Ingelheim, worldwide customers, etc.
Manage validation services to the Production Department. Conducts and participates in investigative meetings relating to validation aseptic manufacturing test failures. Assesses impact of production deviations.
Manage validation service for customers.
Reviews technical reports and test protocols: Reviews and approves all validation test protocols and final reports; reviews and analyzes data contained in the validation test reports to insure compliance with protocol test procedures and specifications; evaluates deviations which occur during the validation test process.
Reviews/approves standard operating procedures: Reviews and approves SOPs dealing with production manufacturing and sterilization processes.
Performs short and long term planning relating to departmental and company needs. Manages departmental budget.
Requirements:
Requires a Bachelor of Science Degree in Engineering / Chemistry /Microbiology or related field.
Minimum 7 years experience in the pharmaceutical business with at least 3 years experience in a supervisory and/or management role. Must be technically competent in the validation requirements for Products, Cleaning Processes, Media Fills, Equipment, Utilities and Facilities/HVAC systems including critical systems such as freeze driers, hot air ovens, autoclaves and water systems. Must have a working knowledge of computerized systems.
Requires understanding of current cGMP regulations and industry standards regarding the validation of aseptic manufacturing processes.
Requires previous participation in cGMP compliance audits initiated by FDA, international governmental agencies and customers.
Requires well developed communication 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 deadlines.,
Requires knowledge of other quality systems in order to participate in validation related investigations and impact assessments.
Develop and direct short and long term planning of validation and re-validation activities as well as company needs.
Plans and assists the Associate Director, Process Validation in the yearly departmental budget (i.e., develops and administers budget).
Must be capable of working independently with minimal supervision.
Must be knowledgeable in windows based software programs (i.e. Microsoft Word, Microsoft Excel, Microsoft Power Point, etc.).
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