Senior QA Validation Lead — Life Sciences Packaging

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 67,400 - 128,700; Full time

Benefits offered by this job

Student loan paydown program & tuition

Family care benefits

Relocation assistance

Inclusion, culture and well-being

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Sr. QA Validation Specialist to validate/qualify equipment, systems, and processes in line with regulatory requirements. You will support manufacturing standards and procedures within a fast-growing, science-driven organization based in Rensselaer, NY, with a Monday–Friday schedule.

The role requires a B.S. in life sciences (or equivalent) and 4+ years (Sr. 6+ years) of QA validation experience, plus responsibility for deviation investigations, change

Qualifications

• B.S in life sciences or related field; may substitute proven experience for education requirement.
• QA Validation Specialist: 4+ years of experience; Sr. QA Validation Specialist: 6+ years of experience.

Responsibilities

• Generates, executes and reviews qualification and validation protocols and reports.
• Analyzes test results against predetermined criteria and documents outcomes.
• Investigates problems and proposes solutions or improvements.
• Reviews and approves deviation notifications, investigations, and corrective actions.
• Coordinates with other departments or vendors to complete validation tasks.
• Performs temperature mapping, packaging qualification, and cold-chain testing.

Skills

QA Validation

Qualification

Deviation handling

Change controls

Documentation

Education

Bachelor's degree in Life Sciences

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Sr. QA Validation Specialist to validate/qualify equipment, systems, and processes in line with regulatory requirements. You will support manufacturing standards and procedures within a fast-growing, science-driven organization based in Rensselaer, NY, with a Monday–Friday schedule.

The role requires a B.S. in life sciences (or equivalent) and 4+ years (Sr. 6+ years) of QA validation experience, plus responsibility for deviation investigations, change