Specialist, Production Execution Systems (3rd shift) - Boehringer Ingelheim
St. Joseph, MO
About the Job
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 Specialist, Production Execution Systems works daily with the core data, monitoring and execution systems for Production (SAP and MES). This role interacts with and maintains master data both in the ERP system (SAP) and the Manufacturing Execution System (PAS-X). The incumbent supports production departments with process support and improvement, thereby impacting economic growth potential by reducing market risk and supporting departmental throughput, outcome and results.
Duties & Responsibilities
+ Reviews master recipes in SAP and MES including XSteps, operations, resources, BOMs and planning recipes.
+ Monitors relevant data in SAP and MES and communicates with end user groups as appropriate.
+ Assists in maintenance of MES MBR and ESP elements.
+ Implements MBR updates due to CAPAs, floor requests or other initiatives.
+ Participates in meetings to review changes with stakeholders and complete assigned CAPAs or action items where applicable.
+ Creates, maintains and reviews XSteps MBRs (master batch records) for Packaging as needed.
+ As needed, assists with batch record evaluation and template implementation across production departments.
+ Provides floor level support for SAP and MES system use with end user training and qualification programs or OJT training.
+ Assists with planning, scheduling, documenting and performance of end user training.
+ Mentors end users through learning of necessary behaviors for system interaction.
+ Assists in day-to-day troubleshooting of SAP and MES systems and/or processes as deemed appropriate.
+ Provides support to end user groups as required.
+ Actively communicates with end user groups regarding best practices, system updates or other information as appropriate.
+ Supports functional area and/or cross functional process improvement initiatives and projects.
+ Actively participates on project teams.
+ Responsible for completing action items as assigned to support implementation of the identified improvements.
+ Actively applies BPE and AAI principles in working through identified improvement initiatives.
+ Supports new product launches and revision of printed components, maintains master recipes to update XSteps, authors and revises MES MBRs (Master Batch Records) and reviews all other relevant information within recipe.
+ When necessary for product launches, completes change control action items.
Requirements
+ Bachelor's Degree in Computer Science, Engineering, Biology or related field and a completed relevant internship or a minimum two (2) years’ experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment.
+ In lieu of a degree, six (6) years’ experience supporting relevant production processes in a cGMP manufacturing facility or similar environment.
+ Must be proficient in MS office applications including Word, Excel, Outlook, etc.
+ Demonstrated proficiency in applicable software applications utilized in production, packaging and/or quality.
+ Ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.
+ Experience in ERP inventory control system(s) is preferred.
+ Experience with MES system is preferred.
+ Qualified Trainer (QT) certification is preferred.
+ SAP key user certification and MES key user certification is preferred.
+ Demonstrated knowledge of relevant production and/or packaging, techniques and equipment is preferred.
+ Working knowledge of cGMP, EU and OSHA guidelines as they pertain to implementing process improvements to production and/or packaging equipment is preferred.
+ Demonstrated ability to train others and complete OJT/training assessments 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.
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 Specialist, Production Execution Systems works daily with the core data, monitoring and execution systems for Production (SAP and MES). This role interacts with and maintains master data both in the ERP system (SAP) and the Manufacturing Execution System (PAS-X). The incumbent supports production departments with process support and improvement, thereby impacting economic growth potential by reducing market risk and supporting departmental throughput, outcome and results.
Duties & Responsibilities
+ Reviews master recipes in SAP and MES including XSteps, operations, resources, BOMs and planning recipes.
+ Monitors relevant data in SAP and MES and communicates with end user groups as appropriate.
+ Assists in maintenance of MES MBR and ESP elements.
+ Implements MBR updates due to CAPAs, floor requests or other initiatives.
+ Participates in meetings to review changes with stakeholders and complete assigned CAPAs or action items where applicable.
+ Creates, maintains and reviews XSteps MBRs (master batch records) for Packaging as needed.
+ As needed, assists with batch record evaluation and template implementation across production departments.
+ Provides floor level support for SAP and MES system use with end user training and qualification programs or OJT training.
+ Assists with planning, scheduling, documenting and performance of end user training.
+ Mentors end users through learning of necessary behaviors for system interaction.
+ Assists in day-to-day troubleshooting of SAP and MES systems and/or processes as deemed appropriate.
+ Provides support to end user groups as required.
+ Actively communicates with end user groups regarding best practices, system updates or other information as appropriate.
+ Supports functional area and/or cross functional process improvement initiatives and projects.
+ Actively participates on project teams.
+ Responsible for completing action items as assigned to support implementation of the identified improvements.
+ Actively applies BPE and AAI principles in working through identified improvement initiatives.
+ Supports new product launches and revision of printed components, maintains master recipes to update XSteps, authors and revises MES MBRs (Master Batch Records) and reviews all other relevant information within recipe.
+ When necessary for product launches, completes change control action items.
Requirements
+ Bachelor's Degree in Computer Science, Engineering, Biology or related field and a completed relevant internship or a minimum two (2) years’ experience in cGMP Aseptic production, Bio manufacturing, pharmaceutical or similar manufacturing environment.
+ In lieu of a degree, six (6) years’ experience supporting relevant production processes in a cGMP manufacturing facility or similar environment.
+ Must be proficient in MS office applications including Word, Excel, Outlook, etc.
+ Demonstrated proficiency in applicable software applications utilized in production, packaging and/or quality.
+ Ability to follow systematic continuous improvement methodologies and the willingness to identify, define, and implement process improvements.
+ Experience in ERP inventory control system(s) is preferred.
+ Experience with MES system is preferred.
+ Qualified Trainer (QT) certification is preferred.
+ SAP key user certification and MES key user certification is preferred.
+ Demonstrated knowledge of relevant production and/or packaging, techniques and equipment is preferred.
+ Working knowledge of cGMP, EU and OSHA guidelines as they pertain to implementing process improvements to production and/or packaging equipment is preferred.
+ Demonstrated ability to train others and complete OJT/training assessments 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.
Source : Boehringer Ingelheim