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 work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Principal Specialist, IPT Training will oversee the implementation and maintenance of a training matrix for operations departments and establish a robust training plan for all new and existing employees. This role is crucial for ensuring that employees are trained on essential skills and knowledge to succeed in their job. The applicant will identify qualified trainers within operations and provide all necessary training in conjunction with the site training group for qualification. The individual will confirm LOS compliance on all OJT's and ensure that all new employees are assigned curriculum for their positions. This individual will drive a quality mindset and continuous improvement initiatives.

Duties Responsibilities

Ensures all employees are qualified to perform required production techniques and activities including, but not limited to, Electronic Batch Records, SAP, environmental monitoring, aseptic processes, cleaning, and disinfection during the production process.

Creates, reviews, and updates OJTs for operations.

Assists with planning, scheduling, and performance of job task analysis.

Ensures compliance with regulations regarding training and qualification of production personnel.

Leads root cause analysis associated with manufacturing deviation investigations.

Assists the investigation of deviations for complex products manufactured and identify the root cause, impact assessment, and CAPA to assess quality requirements to comply with USDA, EU, FDA, or other GMP regulatory requirements and proposes disposition of the product.

Participates on investigation related project teams to evaluate events which are investigated.

Completes maintenance of systems associated with the investigation function.

Participates in project teams assigned to deviation investigations and ensure the proper functioning of systems related to the investigation function.

Responsible for troubleshooting processes and procedures resulting from training that is not satisfactory.

Monitors department training compliance and reporting to management.

Requirements

Bachelor’s degree in microbiology, Biology, or related scientific field.

In addition to bachelor’s degree, a minimum six (6) years’ experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment.

In lieu of degree, a minimum of ten (10) years’ experience supporting relevant production processes in a cGMP manufacturing facility or similar environment.

Experience must be inclusive at least four (4) years leading people and/or moderate to complex process improvement and related production projects.

Demonstrated ability to train others and complete OJT assessments.

Demonstrates the ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.

Experience with word processing, spreadsheets, and database management required.

Must be detail oriented, able to work with minimal supervision and self-motivated to utilize resources to troubleshoot as needed.

Ability to manage multiple on-going projects with aggressive deadlines.

Strong proofreading skills along with excellent communication and written capabilities.

Must be proficient in MS office applications such as Word, Excel, Outlook, etc.

Experience in ERP inventory control system(s) is preferred.

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.

Desired Skills, Experience and Abilities

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.