Associate Director, Process Dev Engineering

Job Description

General Summary:

Vertexs Automation of Machinery and Processes (AMP) Team is seekinga high-impact leaderto developcutting-edgemanufacturingsolutions forits Cell & Genetic Therapies pivotal role is at the forefront of automating complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. You willwork with a passionate team of engineers scientists and innovators united by a shared mission: to push the boundaries ofwhatspossible inCell & Genetic Therapy. This critical position will lead an interdisciplinary engineering team in novel equipment & systems development vendor selection equipment qualification technology transfer and continuous improvement to deliver robust and reliable manufacturing systems.

Key Duties and Responsibilities:

• Lead a team of equipment engineers involved in the design development deployment and qualification of custom automation equipment and operation technology systems used for the development and manufacture of cell and genetic therapies.
• Lead Equipment System and Automaton Projects from concept through execution in a dynamic development environment. Ensures user requirements are clearly defined and translated into achievable and testable engineering requirements.
• Manage and execute the development of mechanical electrical and controls systems for capital equipment. Define automation execution strategy from concept feasibility through commercial deployment. Present to senior leadership as required.
• Responsible for active oversight of the equipment / system design and commissioning process. Collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs.
• Utilize operations simulation tools to identify and quantify automation opportunities.
• Ensures seamless integration of automation control systems into existing enterprise systems.
• Provide hands-on troubleshooting assistance to manufacturing in support of a rapid development cycle and manufacturing sustainability.
• Collaborates with manufacturing engineering to define manage and continuously improve equipment performance preventative maintenance plans and spare parts lists/inventory.
• Evaluate and recommend automation upgrades to existing equipment or systems. Prioritize projects and assign resources to complete projects on-time and within budget.
• Review and/or draft Equipment Drawings Electrical Diagrams System Manuals Engineering Protocols and Reports Validation Documentation and other Quality System Documentation.
• Develop departmental procedures for development and documentation of automated systems from specifications through operational procedures.
• Support Deviation Management CAPA and Change Control activities as required. Serve as Automation SME to Quality Manufacturing and other Functions. Support manufacturing investigations including OOSs OOTs RCAs etc.
• Execute assigned duties on time and within budget; proactively telegraph delays and other issues to relevant stakeholders.
• Comply with all regulatory corporate and Quality System policies and complete other projects and/or assignments as required.

Knowledge and Skills:

• High degree of electromechanical aptitude with prior experience in designing and implementing automated precision manufacturing equipment including integration of vision systems and robotics in bioprocessing medical device pharmaceutical automotive semiconductor or diagnostic systems.
• Ability to organize and grow a team through organizational change and personnel development.
• Experience with automation and equipment business case definition vendor selection and management automation and equipment design development commissioning and validation. Experience developing and executing equipment strategy from concept to deployment.
• Experience working with a variety of automation hardware software and applications including but not limited to custom-fabricated mechanical components and mechanisms single-use bioreactors and bioprocessing instruments vision systems robotics AMR and AGV control systems (PLC DeltaV PC) and related control system components pneumatics automated process instrumentation.
• Experience qualifying/validating/deploying manufacturing equipment and processes is required. Knowledge and experience in utilizing risk-based approaches to validation process development and validation are highly advantageous.
• Familiarity with ISO 13485 ISOCFR 820 21 CFR 211 and ICH Q7/8/9. Knowledge of global GMP requirements governing device or combination products.
• Familiarity with equipment safety standards and regulations including OSHA 19 CFR 1910 NFPA 70 NFPA 79 ISO 18849-1.
• Strong interpersonal project management technical writing and presentation skills required.
• Sense of urgency ability to act/escalate promptly and transparently communicate issues to involved stakeholders and management.
• Must be able to work independently with minimal supervision multi-task and support several projects simultaneously.
• Knowledge of business applications such as MS Office Veeva Coupa.
• Must demonstrate strong interpersonal presentation and teamwork skills.

Education and Experience:

• BS or MS in Mechanical or Electrical Engineering or another relevant discipline.
• Minimum of 12 years of experience (10 with Masters) working in an automation development environment including minimum 3 years working with cGxP equipment.
• Minimum of 3 years in a managerial capacity with experience fostering a culture of quality excellence innovation and collaboration.

Up to 15% domestic and international travel required.

At Vertex we embrace continuous learning and encourage employees to stay informed on advances in AI technology automation and industry trends. We seek talent who bring an external perspective demonstrate curiosity and sound judgment and thoughtfully adopt new capabilities that improve decision-making drive innovation increase efficiency and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

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 persons 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