Principal Specialist, Validation
Company: Boehringer Ingelheim
Posted on: June 25, 2022
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
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
- Develop and maintain higher level departmental and site
standard operating procedures (SOP) and training operations on
- 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
- 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
- Support Engineering and Production Depts. in the selection,
review, acquisition, and upgrade of systems and production
- Provide technical support in developing user and functional
requirements specifications, URS, RA, FRS, and DQ for systems and
- 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
- 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
- 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.
- BS degree from an accredited institution in a relevant
scientific, bioengineering or relevant discipline plus a minimum of
six (6) years GMP validation or similar experience in a GMP
manufacturing or similar production environment or a minimum of 10
years GMP validation experience in a GMP or regulated manufacturing
or similar environment in lieu of a degree.
- Experience must be inclusive of at least two (2) years in
- Ability to plan, schedule, organize, prioritize, and coordinate
- Ability to function in a leadership role and within cross
- Ability to analyze validation and production data to assess
compliance with GMP requirements and/or troubleshoot compliance
- 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
- Must be legally authorized to work in the United States without
- Must be willing to take a drug test and post-offer physical (if
- Must be 18 years of age or older
- This position will require individuals to be fully vaccinated
against COVID-19 or have an approved medical or religious
accommodation. Click here for more information on the vaccine
mandate and COVID-19.
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 boehringer-ingelheim.com 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.
Keywords: Boehringer Ingelheim, Athens , Principal Specialist, Validation, Other , Arnoldsville, Georgia
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