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(Archived) SR/Principal Specialist, Validation

Last Updated: 5/24/23

Job Description

Description: Manage all phases of higher level, more complex validation project activities at the BIAH location from concept through process validation ensuring GMP regulatory compliance continues as outlined in BIAH’s Validation Master Plan (VMP) and Corporate Policies and Procedures. The position is critical to the compliance effort and is responsible for assuring compliance of validated systems, process, and equipment to current cGMP, FDA, EU, USDA, BIAH and BI corporate requirements. This includes, but is not limited to scheduling resources, conducting testing, and verifying facilities, utilities, equipment, systems and processes meet specifications and requirements and are suitable for their intended purposes. Lead project management efforts for validation activities associated with major site capital projects as well as oversee smaller dept. projects and provide technical support to team members. This includes, but is not limited to, contractor oversight, document review, deviation management and CAPA assessment, as applicable. Responsible for the development of Validation specialists as applicable. Provide dept. review/approval to routine validation documents. This position serves as a subject matter expert for internal and external dept./site and global projects as well as a backup for Validation/Tech Services Group/Team Leader and Management in the event of their absence. 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: Responsible for managing higher level, more complex GMP validation project activities at the BIAH sites from concept through process validation as outlined by BIAH’s Validation Master Plan (VMP) and Corporate Policies and Procedures. Maintain site validation database and document systems, support feasibility studies, equipment review, selection, acquisition and upgrade. Develop and maintain higher level departmental and site standard operating procedures (SOP) and training operations on quality principles. Promotes staff development and growth, performs training to staff and other depts. Lead and actively support strategic direction of validation philosophies, improve overall validation system and process flow incorporating into BIAH VMP. Provide over sight and document review for smaller validation projects and routine Validation Maintenance deliverables. Develop and Maintain local standard operating procedures to be in compliance with all FDA/EU/USDA regulations, as well as Corporate procedures. Support maintenance of Validation dept. budget. Serve as backup for Validation Management when needed Serve on assigned internal and external project teams (change controls, deviations, technology transfer, BPE) as a technical/compliance resource to solve quality related issues and/or support continuous improvement. Train Operations personnel in quality and validation principals Support Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment. Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment. Participates with internal, regulatory or corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents. Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready" at all times. Support Change Control, Deviation and CAPA activities Performs all company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH’s excellent reputation in the community. When violations are noted or observed, they are immediately reported to management. This position requires ability to utilize computer programs such as Microsoft suite, SAP,IDEA for CON, Learning One Source and other relevant electronic applications. Understanding of GMP's, compliance requirements, Outlines of Production and 9 CFR knowledge to assess product, procedures, recommend improvements and make correct decisions. Routinely keeps abreast of changes to regulations/compliance requirements through independent study or active involvement in industry related organizations, such as AHI, PTEA, etc. SR Specialist, Validation Requirements: A BS degree from an accredited institution in Engineering, Bioengineering or relevant discipline, and a minimum of four (4) years of validation experience or similar experience in a GMP manufacturing or similar production environment. In lieu of degree, a minimum of eight (8) years of validation experience or manufacturing experience in a GMP or similar regulated manufacturing environment. Experience must be inclusive of two (2) years in leading projects or teams. One to two (1-2) years of Project Management experience. NOTE: Relevant BIAH experience may be weighted more significantly. Principal Specialist, Validation Requirements: BS degree from an accredited institution in a relevant scientific, bioengineering or relevant discipline, plus a minimum of six (6) years of GMP validation or similar experience in a GMP manufacturing or similar production environment. In lieu of a degree, a minimum of ten (10) years of GMP validation experience in a GMP or regulated manufacturing or similar environment. Experience must be inclusive of at least three (3) years in leading projects. Ability to plan, schedule, organize, prioritize, and coordinate project activities. Ability to function in a leadership role and within cross functional teams. Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems. Excellent written and verbal communication skills. Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles. Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks. Ability to make decisions regarding the acceptability of product based on documentation provided. Demonstrated ability to work with diverse groups of people and conflict management. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit and join us in our effort to make more health. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Company Details

Binger Strasse, Germany