Provide project leadership and guidance on validation/qualification initiatives to internal project teams and external validation firms and ensure project schedules are met. Ensure that BIRI systems, both computer and equipment, are in compliance with regulatory requirements. Author, assess, maintain, review and approve validation and qualification lifecycle documentation. Provide guidance on computer system validation and equipment qualification efforts throughout the systems lifecycle.
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:
Serves as project manager for validation/qualification aspects of projects. Arrange for contract validation services when required. This includes contract review, coordination of approvals and interface with contract service personnel in the oversight of the validation activities to make certain resources are available to meet validation project deliverables inclusive of schedule and budget.
Author validation plans; Oversee and provide direction for the development of: specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, and performance of both software and equipment. Provide the Quality Approval on Equipment/Computer Change Controls.
Development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates.
Investigates industry trends in validation and expectations of regulatory agencies and modifies the program to current requirements.
Ensures that the system’s validation state is maintained through proper testing as part of the change control program and re-validation as necessary. Performs a periodic review of systems to monitor the validation status of the system.
Provides training as required to system owners, developers and support personnel on the requirements for validation.
Participate in vendor audits.
Bachelor of Science or Arts degree in a Scientific Discipline, Business, English or a related field.
Minimum five years software validation or equipment qualification experience preferred; five years experience by a combination of equipment qualification, process validation or software validation is acceptable; QA pharma experience preferred
Demonstrated experience in equipment qualification and software validation across multiple applications, systems and equipment types required
Minimum three years experience in project management required with demonstrated ability to manage multiple simultaneous projects
Ability to prepare timelines, schedules and budgets to ensure validation projects are executed on time and within budget.
Experience working with validation and construction contractors to facilitate project deliverables
Knowledge of FDA Current Good Manufacturing Practices (cGMP),GAMP 5 requirements and 21 Code of Federal Regulations (CFR) Part 11 requirements
Experience and Inspection Interaction with FDA, EMA, or other regulatory agencies preferred
Demonstrated proficiency in interpersonal communications, both written (technical writing preferred) and verbal
Excellent planning and organizational skills to be capable of multi-tasking in an environment of high volume projects
Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint)
Must be legally authorized to work in the United States
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...