Job Description
General Summary:
This role will independently build and apply expertise of the POMSnet Aquila Manufacturing Execution System (MES) to support Manufacturing Operations and Supply Chain current and emerging priorities. This role requires working cross functionally to convert business requirements into system requirements then leading the associated implementation activities while ensuring compliance with applicable Quality requirements. Management skills are needed to ensure activities are completed on time and within budget. As a trusted partner, this individual is expected to handle issues when escalated, and champion system improvements to improve operational and supply chain functions.
Key Duties and Responsibilities:
- Manage system master data for rooms, equipment, recipes, worksheets, items, material flows, and other elements as required.
- Author minor configuration changes to MES worksheets and recipes
- Provide training and resolution to system issues when an escalation path is needed.
- Understand Vertex goals and apply them to improve the MES system in a targeted manner.
- Work cross functionally with the Vertex Quality organizations and DTE to ensure implementations, change controls, change actions, documentation revisions and similar are completed in a compliant manner.
- Demonstrate how MES and integrated digital systems improve quality, reduce defects and improve efficiency. Translate this into KPI's and dashboards for stakeholder review.
- Envision what the MES user interface will consist of and work with stakeholders and a recipe author to optimize the system
- Manage the change request backlog
- Develop and execute to a schedule, communicate to key stakeholders at appropriate frequency, and escalate when required.
- Complete all training and assigned tasks on-time while delivering effective solutions.
Knowledge and Skills:
- Proficient user of POMSnet Aquilla MES or equivalent MES system.
- Knowledgeable in object-based programming and Phase Transition Logic concepts.
- Understanding design methodologies for recipes and worksheets used in Cell and Gene Therapy Manufacturing.
- Proficient understanding of recipe authoring concepts used in object based and phase transition logic programming.
- Proficient in GMP principles and the Quality Management systems.
- Proficient understanding of the digital system landscapes as deployed in the Biopharmaceutical industry.
- Work cross functionally to prioritize tasks and align with business needs by gathering end user data and converting them into system requirements.
- Proven ability to successfully operate in a dynamic, high impact, and highly visible role.
Education and Experience:
- Typically requires 3 years of experience working with POMSnet Aquilla MES or similar system.
- BS in a Science, Engineering, or equivalent related field.
- Experience working in a GMP Manufacturing or another regulated environment.
- Proficient in Microsoft Office
#LI-onsite
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
Top Skills
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases.
We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development.
Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.