Package Engineering Manager

Job Description

General Summary:

Key Duties and Responsibilities:

• Maintains effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resources
• 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
• Supports packaging projects and process improvement efforts, validations, equipment installation, IQ/OQ/PQ protocol development and execution
• Participates on cross-functional CMC sub-teams
• Evaluates process performance to identify and lead continuous improvement activities for commercial products
• Supports resolution of quality investigations
• Works effectively with multiple stakeholders including Pharmaceutical Sciences, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines and objectives
• Acts as a resource in the assigned technical area
• May lead aspects of technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents
• Will require travel to contract manufacturing plants to support process performance or to troubleshoot manufacturing issues
• Supports the responsibilities of the technical operations team in projects related to packaging technology, sustainability, and industry activity
• Experience or certification in LEAN and/or Six Sigma practices is a plus

Knowledge and Skills:

• Ability to travel domestic and international. (Approximately 25%)
• Good knowledge of cGMP's and associated CMC regulatory considerations in a pharmaceutical environment
• Fundamental understanding and application of validation processes (IQ/OQ/PQ/PV)
• Ability and flexibility to work globally in a virtual work environment
• Excellent project management experience
• Solid communication, analytical, problem solving and collaboration skills to exchange complex information with others in complex situations
• Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities

Education and Experience:

• Bachelor's degree in Packaging, Chemical, Mechanical, Material or Industrial Engineering, or a related field
• Typically requires 4 years of experience or the equivalent combination of education and experience

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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 ApplicationAssistance@vrtx.com