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

BW Design Group; Boston (MA); On-site; USD 95,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

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

Skills

Technical writing skills

cGMP regulations knowledge

Project management

Communication skills

Problem-solving abilities

Microsoft Office Suite

Education

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

Master's degree (MS/MSc)

Tools

Electronic validation systems

Job description

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.