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

The **Principal Specialist, MES** executes Manufacturing Execution Systems (MES) functions within the Regional MES deployment team and between related departments. Using material and batch information in SAP and MES, creates and maintains master recipes and master batch records to document production processes for the manufacture of biological vaccines. This role interacts with Production, Quality Management and Production Planning groups on all scheduled GBS related items for both the SAP and MES systems. The incumbent ensures that the Production departments have accurate master recipes and executable master batch records to perform production. Duties for this role will include documentation of work, provide direction, assistance, technical support, and maintain compliance at both the local and global levels. These initiatives may be functional area specific or cross functional in nature.

The **SR Principal Specialist MES** is responsible as the project/design manager for MBR design activities across multiple sites in the region. This role coordinates the deployment related Production Execution Systems (PES) functions within each site PES team, area leadership, and between related departments. The incumbent interacts in a highly cross-functional environment to ensure SAP and MES solutions support the needs of Production and Quality Management. This role assists the Regional Manufacturing Process Lead, Regional MES Engineer, and local PES Production teams with process improvement prior to phase deployment. Other duties will include providing informal leadership to less experienced design team members, resource planning, documentation of work, provide direction to other local team members, assistance, technical support and maintain compliance at both the local and global levels for MES implementation and sustainment. These initiatives may be functional area specific or cross functional in nature.

Responsibilities

SENIOR PRINCIPAL

Responsible for design management for MBR design activities at each site related to deployment of MES to all production departments.

Responsible for MBR design activities include records for deployment to new production areas and may also support new launch/transfer of products into the deployed production areas.

Manages and delivers projects and processes for Operations with quality which impact economic growth potential, reduce market risk and support site throughput outcomes and results to meet key performance indicators.

Directly responsible for the expansion and development of MES across the organization in support of advancing and growing the business.

Leads the creation and maintenance as needed of master recipes in SAP and master batch records in MES.

Provides guidance for both PES and other Production related to best practices.

Serves as BIAH representative for the PAS X Regional User Group consisting of various pharmaceutical and vaccine manufacturers utilizing and integrating MES.

Serves as SME in all ERP functionality related to PE regarding usage of SAP, SAP Master Recipes, MES and with understanding of related workstreams. The technicality of this role assumes local and global support activities when needed.

Leads and/or supports process improvement initiatives and project teams.

Leads and mentors the lesser experienced team members with expertise to ensure appropriate documentation and procedures have been followed during the design process.

Incorporates process improvement methodologies i.e. 5-step method for problem solving, six sigma, lean manufacturing, etc in working with project teams.

Identifies and formulates tactical solutions to assigned areas of focus.

Responsible for regularly coordinating and communicating with support functions such as Production Planning, Quality Assurance, Maintenance, Engineering or other cross functional areas in support of process improvement and other maintenance activities to meet requirements and timelines.

Responsible for leading/managing multi-site CAPA implementation, auditing and revision of standard operating procedures for compliance related to MES processes and MBR creation and updates.

Responsible for overseeing the regular coordination and communication with support functions such as Quality Assurance, Maintenance, Engineering or other cross functional areas in support of CAPA implementation and process/documentation improvement activities.

Creates, reviews, and updates OJT and MBR curricula and compliance requirements.

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

Ensures Regulatory Compliance regarding process order data and batch records.

Assists with regional change controls, BOM and planning recipe updates to ensure compliance and correct costing of products.

Performs other duties as required.

Requirements

PRINCIPAL:

Bachelor’s degree in STEM field, Business or related are of focus with a minimum of six (6) years’ experience implementing MES activities, supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required.

OR

In lieu of degree, a minimum of ten (10) years’ experience implementing MES activities, supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required.

Experience must be inclusive of a strong, working knowledge of SAP and applicable systems.

Strong decision making, communication, planning and organizing abilities.

Prior experience with MES system required.

SAP and MES Key User Certification is required at time of hire or within six (6) months of hire.

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

Demonstrated knowledge of relevant production and/or packaging techniques and equipment.

Demonstrated proficiency in applicable software applications utilized in production and/or packaging.

A working knowledge of cGMP, EU and OSHA guidelines as they pertain to implementing process improvements to production and/or packaging equipment.

Demonstrated ability to train others and complete OJT/training assessments.

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

Travel requirement of 30%.

SENIOR PRINCIPAL:

Bachelor’s degree in a STEM field, Business or related area of focus with a minimum of eight (8) years’ experience implementing MES activities, supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required.

OR

+ In lieu of degree, a minimum of twelve (12) years’ experience implementing MES activities, supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required.

+ Minimum of two (2) years’ experience with PAS X or other MES related software required.

+ Proven experience as a project manager including formal or informal leadership of project team.

+ Demonstrated decision making, communication, planning and organizing abilities.

+ Organizational change management experience is preferred.

+ Relevant industry experience must be inclusive of a strong, working knowledge of MES, ERP and applicable systems.

+ Must be proficient in MS office applications including Project, Word, Excel, Outlook, etc.

+ Demonstrated knowledge of relevant production and/or packaging techniques and equipment.

+ Demonstrated proficiency in applicable software applications utilized in production and/or packaging.

+ A working knowledge of cGMP, EU and OSHA guidelines as they pertain to implementing process improvements to production and/or packaging equipment.

+ Demonstrated ability to train others and complete OJT/training assessments.

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

+ Travel requirement of 30%.

**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.

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.