Equipment Validation Engineer – CQV for Biotech

Alliancebiotechsolutions; Raleigh (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Dental and Vision Insurance

Paid long-term and short-term disability

401K plan with employer contributions

Job summary

Alliance Biotech Solutions in Raleigh, North Carolina, is seeking a Validation Specialist to support equipment qualification activities in GMP-regulated environments. The ideal candidate will have 2+ years of experience with CQV activities and strong knowledge of GMP regulations. Responsibilities include executing validation protocols, investigating discrepancies, and collaborating with cross-functional teams. The position offers competitive wages and benefits including dental and vision insurance and a 401K plan.

Qualifications

• 2+ years experience in GMP-regulated environments for mid-level or 5+ years for senior.
• Experience with equipment qualification and single-use technologies preferred.
• Ability to interpret technical documentation including process flow diagrams.

Responsibilities

• Execute and support equipment qualification activities.
• Participate in qualification of lab instruments.
• Investigate deviations and perform root cause analysis.

Skills

Supporting CQV/validation activities

Understanding GMP regulations

Technical writing

Problem-solving capabilities

Communication skills

Job description

Alliance Biotech Solutions in Raleigh, North Carolina, is seeking a Validation Specialist to support equipment qualification activities in GMP-regulated environments. The ideal candidate will have 2+ years of experience with CQV activities and strong knowledge of GMP regulations. Responsibilities include executing validation protocols, investigating discrepancies, and collaborating with cross-functional teams. The position offers competitive wages and benefits including dental and vision insurance and a 401K plan.