Automation Principal Engineer

Job Description

JOB TITLE: Automation Principal Engineer  

LOCATION: 1 Harbor Street, Boston, MA 02210

OPENINGS: 1

DUTIES:

• Contribute to operations on the Development and Launch Rig (DLR), Vertex’s novel pharmaceutical production system.

• Participate in automation design and development of digital solutions to enhance manufacturing efficiency.

• Collaborate extensively with colleagues at the Manufacturing Center as well as others in Pharmaceutical Sciences and Manufacturing.

• Act as a critical contributor to understanding automation and/or process issues during production, with the ability to troubleshoot and resolve issues in a GMP-compliant manner.

• Interpret multidimensional data sets and make recommendations on process improvements and root cause assessments.

• Oversee the maintenance and expanded use of the PI historian system and associated data analytics tools.

• Partner with cross-functional teams to ensure adherence to production schedules, while delivering automation solutions which meet business needs.

• Support development of new automation processes and the procedures for administration of those processes.

• Maintain the 21 CFR Part 11 compliance and data integrity of all manufacturing computer systems.

• Draft, update, and routinely verify system specifications and standard operating procedures (SOP) for the automation systems supported.

• Train users on control system functionality (process control, computer/control networks, and instrumentation).

• Administer all aspects of the control system life cycle in a regulated environment.

• Keep all software and documentation up-to-date and in a state of compliance.

• With minimal guidance, schedule and lead a team through the planning and execution of automation projects, or a defined piece of a larger project.

• Execute manufacturing campaigns on the DLR, for both development and commercial activities.

• Stay abreast of scientific literature and champions relevant emerging technology in discipline as a technical resource.

• Transfer in-depth and conceptual technical knowledge to Contract Manufacturing Organizations (CMOs) for equipment qualification and commercial production.

REQUIREMENTS: Employer will accept a Bachelor's degree in Electrical Engineering, Chemical Engineering, Computer Science, Automation Engineering or a related field and 10 years of experience in the job offered or in an Automation Principal Engineer-related occupation.

Alternatively, employer will accept a Master’s degree in Electrical Engineering, Chemical Engineering, Computer Science, Automation Engineering or a related field and 7 years of experience in the job offered or in an Automation Principal Engineer-related occupation.

Position requires demonstrable experience in the following:

Ability to build and analyze process trends and draw appropriate conclusions and recommend actions based on complex data sets. Experience in computer systems validation and commissioning for the pharmaceutical industry. Ability to manage or support Quality Systems in a cGMP environment including Change Control, CAPA, and Deviations. Ability to administer data archiving tools including Aveeva PI or Nugenesis. Ability to program PLC hardware including Siemens or Rockwell platforms. Ability to administer all aspects of the control system life cycle in a regulated environment including document control and software version control. Ability to maintain the 21 CFR Part 11 compliance and data integrity of all manufacturing computer systems. Ability to troubleshoot automation systems including 24VDC control circuits, VFDs, servos, and sensors.

CONTACT: Send Resume to Sarah Hadjian at [email protected]. Reference 12140.385. EOE.

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Flex Designation:

On-Site Designated

Flex Eligibility Status:

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 [email protected]