Principal Engineer, Process Engineering (Cell & Gene Therapy)

Job Description

Vertex MSAT team is seeking a Principal Engineer to join a growing team in support of commercial Cell and Gene Therapy programs. This position will be responsible for providing technical support and leadership in alignment with defined program priorities linked to drug substance and drug product with focus on process equipment design and qualification, process automation/robotics and digital data systems.

This is a Boston based, hybrid position (3 days/week onsite).

Key Responsibilities:

• Identify and develop technical solutions to enable program and company goals.

• Lead the design and implementation of efficient and scalable manufacturing processes for commercial application, working closely with cross functional teams including process development, manufacturing, and engineering. The role includes the design and execution of process scale-up strategies and technologies, with the potential to design and implement novel equipment and manufacturing platforms for cell therapy programs. This includes the assessment of advanced automated systems, including robotics, artificial intelligence, and digital data systems.

• Establish process equipment selection and user requirement specifications to enable efficient facility installation and qualification.

• Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial robustness/reliability.

Minimum Requirements:

• PhD with 5+ years, MS with 7+ years, or BS with 9+ years of experience.

• Significant experience leading equipment design, FAT/SATs, qualification, and validation.

• Experience leading projects with minimal oversite.

• Experience with large-scale GMP manufacturing for biopharmaceutical manufacturing, specifically facility design and process fit/transfer methodologies.

• Experience with process automation/robotics is preferred.

• Knowledge of vision or other automated inspection systems.

• Experience with cGMP regulations/guidance and with regulatory agency inspections preferred.

• Experience with inline process analytical technologies (PAT) for real time assessment of manufacturing performance is preferred.

• Experience working with external partners (CMOs, vendors, etc.).

• Ability to travel, nationally and internationally, up to 10 - 15%.

• Flexibility to work on site a minimum of 3 days per week.

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Flex Designation:

Hybrid-Eligible Or On-Site Eligible

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