Senior Validation Engineer - GMP Systems Lead

Emergent BioSolutions; Canton (MA); On-site; USD 129,000 - 156,000; Full time

Job summary

Emergent BioSolutions in Canton, MA seeks a Sr. Engineer, Validation to ensure cGMP compliance across the validation program. You will lead multi-disciplinary projects, provide SME guidance across commissioning, qualification and validation, and drive improvements in performance and quality.

The role requires extensive experience in CIP/SIP, PQ, and regulatory inspections, with strong leadership and collaboration skills to support manufacturing sciences, quality, and engineering teams.

Qualifications

• BSEngineering/Chemistry/Microbiology or related field is required.
• 8+ years related industrial experience in system qualification or validation.
• Expert knowledge of validation principles and concepts.
• Experience with GMP and regulatory expectations (GxP).
• Strong communication and ability to work independently in teams.

Responsibilities

• Create and execute CX/IQ/OQ/PQ commissioning, qualification protocols and plans.
• Provide guidance on equipment, system, and facility commissioning and qualification.
• Review and approve system lifecycle docs (URs, FS, DS).
• Perform equipment, aseptic processing, steam sterilization and process validation.
• Report status of qualification activities to leadership.
• Represent validation on internal teams and at technical conferences.

Skills

Strong communication

Independent work

GxP knowledge

Problem solving

Education

BS Engineering/Chemistry/Microbiology or related field

Tools

Kaye AVS

Microsoft Word

Microsoft Excel

PowerPoint

ISPE guidelines knowledge

Job description

Emergent BioSolutions in Canton, MA seeks a Sr. Engineer, Validation to ensure cGMP compliance across the validation program. You will lead multi-disciplinary projects, provide SME guidance across commissioning, qualification and validation, and drive improvements in performance and quality.

The role requires extensive experience in CIP/SIP, PQ, and regulatory inspections, with strong leadership and collaboration skills to support manufacturing sciences, quality, and engineering teams.