Senior Validation Eng II/III – Gene Therapy Manufacturing

Genezen; Lexington (MA); On-site; USD 105,000 - 130,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match up to 6

Health plans

FSA and HSA programs

Life insurance

Disability insurance

Job summary

Genezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and process qualification activities. The role will assist in process transfers, scale-up, and process validation efforts while ensuring compliance with internal procedures, cGMPs and regulatory requirements.

Responsibilities include preparing validation protocols and reports, supporting the manufacture of cGMP materials, conducting risk

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Biological Sciences, or a related technical discipline.
• 5–8 years of validation experience.
• Experience in clean room environments and aseptic fill/finish.
• Familiarity with validation lifecycle management and continued process verification.
• GxP regulations knowledge including 21 CFR Parts 11, 210/211, EU GMP Annex 1 and 11, ICH guidelines.

Responsibilities

• Generate, execute, analyze data, and prepare qualification protocols and reports.
• Review qualification documentation on behalf of the validation department.
• Support investigations for nonconformances and CAPAs.
• Own validation change controls and associated actions.
• Write SOPs related to validation practices.
• Review engineering docs such as P&IDs and equipment specs.
• Support commissioning-to-qualification transitions.
• Assist risk assessments and validation program implementation.
• Identify opportunities to improve validation processes and timelines.
• Assist audits and regulatory inspections as needed.

Skills

Cross-functional collaboration

Verbal and written communication

Documentation writing

Problem solving

Education

Bachelor's degree in Engineering or life sciences

Tools

Excel

Word

PowerPoint

Visio

P&IDs

Job description

Genezen is hiring a Validation Engineer II/III to support validation and manufacturing operations by executing and documenting equipment, utility, facility, and process qualification activities. The role will assist in process transfers, scale-up, and process validation efforts while ensuring compliance with internal procedures, cGMPs and regulatory requirements.

Responsibilities include preparing validation protocols and reports, supporting the manufacture of cGMP materials, conducting risk