Senior GxP Site Engineer | Facilities & Compliance

Vertex Inc.; Boston (MA); On-site; USD 104,000 - 156,000; Full time

Job summary

Vertex Inc. is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for process, facility, instrumentation, and regulatory needs at Vertex GxP Facilities.

You will collaborate with Facilities Operations, Advanced Manufacturing Engineering, and cross-functional teams to meet manufacturing needs and lead equipment/facility infrastructure engineering efforts. The role requires 3–6 years in GxP engineering, a B.S.

Qualifications

• 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.

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 including engineering drawings, reports, P&IDs, user requirements specifications, CQV documents, and SOPs.
• 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 in troubleshooting of process equipment, facility equipment and associated utilities to resolve discrepancies.

Skills

cGMP compliance

Facility design

P&IDs interpretation

Regulatory knowledge

Team collaboration

Education

Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering

Job description

Vertex Inc. is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for process, facility, instrumentation, and regulatory needs at Vertex GxP Facilities.

You will collaborate with Facilities Operations, Advanced Manufacturing Engineering, and cross-functional teams to meet manufacturing needs and lead equipment/facility infrastructure engineering efforts. The role requires 3–6 years in GxP engineering, a B.S.