Senior Specialist, GxP Site Engineering

Job Description

General Summary:

The GxP Site Engineering Senior Specialist will be a single point of contact of all Engineering needs from process, facility, instrumentation, and regulatory needs for Vertex’s Cell and Gene Device Manufacturing Facility. The Site Engineering GxP Senior Specialist will collaborate with Facilities Operations, Advanced Manufacturing Engineering, Project Engineering, PMO, CMC teams and Site Leadership to meet all facility and manufacturing needs. This role will involve various aspects of equipment, and facility infrastructure-focused engineering efforts.

Key Duties and Responsibilities:

• Collaborate with scientific groups to learn and understand the evolving science and technology.
• Executes change management for facility and other support systems including commissioning and/or implementation of other related initiatives as assigned.
• Implement science centric strategic decisions for capital projects based on scientific knowledge, education and experience.
• Participate in design reviews for various capital projects and new equipment with cost, efficiency and compliance always in mind.
• Creation, revision, and review of system lifecycle documentation. This includes, but not limited to, engineering drawings and design documents, reports, P&IDs, user requirements specifications, CQV documents (commissioning protocols, IOPQs), and SOP’s.
• Perform engineering assessments for new capital equipment/projects.
• Provide SME support for regulatory inspections from facility design and engineering standpoint.
• Influence peers to consistently implement continuous improvements to existing and new facilities/equipment.
• Collaborate to ensure all Engineering KPIs are appropriately monitored, tracked, and reported.
• Lead and participate (as needed) in troubleshooting of process equipment, facility equipment and associated utilities to resolve any observed discrepancies.
• Work collaboratively with Manufacturing, Process/Analytical Development, R&D groups, EH&S, Capital Project Management, DTE, QA, Advanced Manufacturing Engineering, Project Engineering and others to support the consistent achievement of the company’s strategic objectives.

Cultivate change and innovation by seeking opportunities to strengthen and improve existing engineering services.

Knowledge and Skills:

• Knowledge of cGMP and regulated facility design, change control processes, compliance requirements, commissioning, qualification, validation, and best practices in the pharmaceutical industry.
• Experience with Cell and Gene Therapy equipment and processes design
• Ability to read, interpret, and redline engineering drawings (P&IDs, I&C Diagrams, Electrical Panel Schedules, etc.), and be able to perform engineering calculations
• Understanding and application of technical principles, theories, and concepts in the field, and familiarity with industry best practices and standards (GMP, GEP, ISO, GAMP, BPE, ISA, ANSI, etc.).
• Knowledge of facility related engineering disciplines (MEP) in GMP manufacturing environment.
• Familiarity with sterile manufacturing regulations such as ISO 13485, Annex 1 and applicable FDA 21 CFRs.
• Developed verbal and written communication skills and interpersonal skills to explain complex information to others in a straightforward fashion.
• Strong interpersonal skills, including the demonstrated ability to manage through influence.
• Must exhibit mechanical abilities including tool familiarity, lifting, climbing a ladder and gowning into cleanrooms.
• Candidate must be responsive to change and adapt quickly to changing circumstances.
• Must demonstrate effective self-management and act on improvement opportunities.

Education and Experience:

• Typically requires 4-6 years of relevant work experience in GxP Engineering; OR, any equivalent combination of experience and/or education from which comparable knowledge, skills, and abilities have been achieved.

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]