Senior Validation Engineer (GMP/CSV) - Lead & SME

BW Design Group; Boston (MA); Presencial; USD 95.000 - 120.000; Jornada completa

Descripción de la vacante

BW Design Group is seeking a Validation Engineer III in Boston, MA, to provide expert-level support in ensuring that facility equipment and processes are qualified under cGMP standards. This role involves leading validation projects, authoring protocols, and guiding teams across functions. Candidates should possess a Bachelor's degree in Engineering or Life Sciences and have at least 5 years of relevant experience in regulated environments. Strong technical writing and project management skills are essential, along with knowledge of cGMP regulations.

Formación

• Minimum 5+ years of professional experience in validation, engineering, or operations.
• Experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment.
• Ability to work independently and in a team environment.

Responsabilidades

• Author and review validation protocols and reports.
• Lead validation-related project activities including scheduling and execution.
• Manage external vendors and qualification activities.

Conocimientos

Technical writing skills

cGMP regulations knowledge

Project management

Communication skills

Problem-solving abilities

Microsoft Office Suite

Educación

Bachelor's degree in Engineering, Life Sciences, or related discipline

Master's degree (MS/MSc)

Herramientas

Electronic validation systems

Descripción del empleo

BW Design Group is seeking a Validation Engineer III in Boston, MA, to provide expert-level support in ensuring that facility equipment and processes are qualified under cGMP standards. This role involves leading validation projects, authoring protocols, and guiding teams across functions. Candidates should possess a Bachelor's degree in Engineering or Life Sciences and have at least 5 years of relevant experience in regulated environments. Strong technical writing and project management skills are essential, along with knowledge of cGMP regulations.