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 Senior Principal Specialist, Production Execution Systems will be the project manager for MBR design activities at the site. This role coordinates the Production Execution Systems (PES) functions within the 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 MES Engineer and PES Production team with process improvement prior to phase deployment, as well as continuous improvement of Production processes after deployment. Other duties for this position will include providing informal leadership to less experienced PES team members, resource planning, documentation of work, providing direction to other PES team members, assistance, technical support and maintaining 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. The incumbent performs other duties as required.

Duties & Responsibilities

Responsible for project management of MBR design activities at the site related to deployment of MES to all production departments. MBR design activities include records for deployment to new production areas and 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 PES 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 CAPA implementation, auditing, and revision of standard operating procedures for compliance related to PES 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 & MBR curricula and compliance requirements.
Assists with planning, scheduling, and performance of job task analysis.
Ensures Regulatory Compliance regarding process order data and batch records.
Assists with change controls, BOM and planning recipe updates to ensure compliance and correct costing of products.

Requirements

Bachelor's Degree in STEM or related field and minimum eight (8) years relevant industry experience.

Twelve (12) years' experience supporting relevant production processes in a cGMP manufacturing facility or similar environment in lieu of degree.
Minimum of 4 years' experience with PAS X or other MES related software is 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.
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.

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.