Principal Specialist - Validation
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Job Description
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 several ways to foster a healthy working environment meaningful work diversity and inclusion mobility networking and worklife balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees.
The Principal Specialist Validation manages all phases of higher level more complex validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAHs Validation Master Plan (MVP) and Corporate Policies and Procedures. This position is critical to the compliance effort and is responsible for assuring compliance of validated systems process 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.
The Principal Specialist Validation will lead project management efforts for validation activities associated with major site capital projects as well as oversee small department 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. Provide department review/approval to routine validation documents. This position serves as a subject matter expert for internal and external department/site and global projects.
- Bachelor Degree in a relevant scientific bioengineering or relevant discipline
- Six (6) years GMP validation or similar experience in a GMP manufacturing or similar production environment
- Minimum of ten (10) years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees.
- Experience must be inclusive of at least three (3) years leading projects.
- Computer Systems Validation: CFR Part 11 compliance experience preferred.
- Ability to plan schedule organize prioritize and coordinate project activities.
- Ability to function in a leadership role and within cross function 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.
- Skillful in using office application software (MSWord MSExcel MSOutlook PowerPoint).
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and postoffer physical (if required).
- Must be 18 years of age or older.
Employment Type
Full Time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
