GxP Site Engineering Senior Specialist

## GxP Site Engineering Senior Specialist Apply:
Boston, MA:
Full time:
Posted Today:
REQ-30200
** Job Description
**** General

Summary:

** The GxP Site Engineering Senior Specialist will represent Global Engineering for Engineering needs from process, facility, instrumentation, and regulatory needs for Vertex GxP Facilities. The GxP Site Engineering 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, Oral Solid Dose, or Biologics facility 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 GMP manufacturing regulations such as 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 clean rooms.
* Candidate must be responsive to change and adapt quickly to changing circumstances.
* Must demonstrate effective self-management and act on improvement opportunities.
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* Educati…