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SalaryJob Description
Vertex is seeking a detail-oriented Package Engineering Senior Specialist with technical expertise in pharmaceutical packaging, process development and continuous improvement initiatives. The ideal candidate will provide technical support in packaging operations, working with cross functional teams in a fast-paced environment. Candidate will need to ensure resolution of technical issues with Contract Manufacturers and Distribution Centers. They will support projects with on-time review and implementation of documentation, and change controls. Candidate should have excellent problem solving, organizational, interpersonal, oral, and written communication skills, and experience with technical writing, cGMP and regulatory CMC requirements.
KEY RESPONSIBILITIES:
- Provides technical support on Packaging processes to Package Engineering and cross functional teams
- Author and/or review validation and change control documents such as master batch records, protocols, reports and change requests.
- Experience in software systems for validation protocols, change controls, CAPAs and Deviations.
- Experience with common primary, secondary, and tertiary packaging materials
- Supports packaging projects and process improvement efforts (IE New Product Introductions, validations, equipment installation, IQ/OQ/PQ protocol development and execution
- Ability and flexibility to work globally in a virtual work environment
- Excellent project management experience
- Ability to multitask to effectively manage multiple activities and projects
- Ability to collaborate with and communicate results to relevant stakeholders
- Strong analytical, problem solving and communication skills
- Develops solid working relationships with relevant technical individuals or teams at contract manufacturing sites
- Will require travel periodically to contract manufacturing plants to support process performance or to troubleshoot manufacturing issues
- Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
- Supports the responsibilities of the Packaging LCM team in projects related to packaging technology, sustainability, and industry activity
- Experience or certification in LEAN and/or Six Sigma practices is a plus
Education and Experience:
- Typically requires Degree in Packaging, Biomedical, Mechanical, Chemical, or Industrial Engineering or a related field.
- Minimally requires 3 years of experience or the equivalent combination of advanced education and experience.
Required Knowledge/Skills
- Advanced knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
- Fundamental understanding and application of validation processes (IQ/OQ/PQ/PV)
- Solid communication, collaboration and team building skills; ability to connect with all levels of the organization
- Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities
Other Requirements
- Ability to travel domestic and international. (Approximately 25%)
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.
