GxP Site Engineering Senior Specialist
Vertex Pharmaceuticals · Boston, MA
QualityFull-time$104k–$156kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Vertex Pharmaceuticals seeks a GxP Site Engineering Senior Specialist in Boston to oversee facility and equipment engineering for regulated pharmaceutical manufacturing. The role requires collaborating across teams to manage capital projects, system lifecycle documentation, and regulatory compliance while supporting process and facility infrastructure.
What they're looking for
- Bachelor's degree in Chemical, Mechanical, Electrical Engineering, or related discipline
- 3-6 years of GxP engineering experience in pharmaceutical manufacturing
- Knowledge of cGMP, commissioning, qualification, validation, and regulated facility design
- Experience with Cell and Gene Therapy, Oral Solid Dose, or Biologics facility design
- Ability to read, interpret, and redline engineering drawings and perform calculations
- Familiarity with FDA 21 CFRs and industry standards (GMP, GEP, ISO, GAMP, BPE, ISA, ANSI)
- Strong written and verbal communication skills with proven ability to manage through influence
What you'll be doing
- Collaborate with scientific and operations teams to understand evolving technology and facility needs
- Execute change management and commissioning for facility systems and capital projects
- Create, revise, and review system lifecycle documentation including P&IDs, specifications, and validation protocols
- Participate in design reviews and engineering assessments for equipment and projects with compliance focus
- Lead troubleshooting efforts for process equipment and facilities; provide SME support for regulatory inspections
Privacy & handoff
This role links to Vertex Pharmaceuticals's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.