Job Description
Job Description
General Summary:
The Manufacturing Operations Senior Specialist role supports both clinical and commercial manufacturing of pharmaceutical drug product conforming to cGMP requirements. This role works with drug product development teams through all phases up to and including commercialization, as well as operating and maintaining the Drug Product Facility including the continuous manufacturing equipment. Additionally, the Manufacturing Operations Senior Specialist performs a variety of support functions as determined by management and the needs of the department.
The Senior Specialist will be responsible for providing functional and technical support in the implementation and maintenance of the Manufacturing Execution System (MES).
Key Duties and Responsibilities:
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Collaborate with business stakeholders to understand their current future state strategy, needs, and requirements.
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Assist in business process system design.
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Identify opportunities for business process improvements using system solutions.
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Help create and execute testing plans.
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Author and manage change controls, documents and training materials.
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Assist in the procurement, deployment, and troubleshooting peripheral devices used in manufacturing.
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May work with POMsnet Aquila MES or other MES deployed in a GMP environment
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Work closely with DTE and QA groups as needed to ensure compliance with GMP regulations, data integrity, and lifecycle change management requirements
Knowledge and Skills:
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Ability to lift up to 40lbs, visual acuity, manual dexterity, and ability to distinguish between the colors red, yellow, blue, and green
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Knowledge of cGMP requirements for manufacturing
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Solid organizational, interpersonal, communication, and documentation skills
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Ability to follow written and oral instructions in English
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Advanced computer skills and ability to learn new systems
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Basic programming knowledge
Education and Experience:
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Bachelor’s or Master's degree in Engineering, Science, Statistics, Math, IT (Software Dev, Engineer), Data Scientist or related field and at least 3 years of experience in a manufacturing environment
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 ApplicationAssistance@vrtx.com.