Principal Specialist, Production Execution Systems

3 weeks ago

St Joseph, United States Boehringer Ingelheim Full time

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, Production Execution Systems assists the supervisor in coordinating the Production Execution Systems (PES) functions within the PES team and between related departments. Using material and batch information in SAP and MES, the incumbent 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 Principal Specialist, Production Execution Systems 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. Performs other duties as required.

Duties & Responsibilities

  • Serves as SME in all ERP functionality related to PE regarding usage of SAP, SAP Master Recipes, XSteps, MES and with understanding of related workstreams. The technicality of this role assumes local and global support activities when needed.
  • Supports schedule adherence for Operations projects and processes which impact economic growth potential, reduce market risk and support site throughput outcomes and results.
  • Creates and maintains Master Recipes in SAP including XSteps and master batch records in MES.
  • Directly responsible for the expansion and development of MES across the organization in support of advancing and growing the business.
  • Oversees release and status of process orders and/or manufacturing orders for Operations as well as the maintenance of XSteps/MES.
  • 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 CAPA implementation and process improvement activities to meet requirements and timelines.
  • Leads process improvement initiatives; supports process improvement initiatives and/or project teams.
  • 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.
  • Supports the PES team as an SME to ensure appropriate documentation and procedures have been followed during the production process.
  • Responsible for CAPA implementation, auditing and revision of standard operating procedures for compliance related to PES processes and MBR creation and updates.
  • Responsible for regularly coordinating and communicating 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.
  • Serves as key user for SAP and MES at the site and assist with training of production employees.
  • Runs reports weekly and at month end to ensure all are complete.
  • Reviews and assists with evaluation of variance reports to update master recipes as required.

Requirements

  • Bachelor’s Degree in Biopharmaceuticals or related field and minimum six (6) years relevant industry experience.
  • In lieu of degree, ten (10) years’ experience supporting relevant production processes in a cGMP manufacturing facility or similar environment in lieu of degree.
  • Relevant industry 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.
  • 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.

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