Pharma Lab Validation Engineer – cGMP & 21 CFR 11

Integrated Resources Inc.; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Integrated Resources, Inc. is seeking a Quality Control Validation Specialist in Durham, NC. The ideal candidate must have expertise in validating laboratory instruments in a pharmaceutical setting, with a thorough understanding of FDA regulations and cGMP standards. This role involves developing validation documents, ensuring compliance, and leading risk assessments. Candidates should possess at least four years of relevant experience and demonstrate strong attention to detail in compliance with regulatory requirements.

Qualifications

• Minimum 4 years’ experience validating equipment.
• Minimum 2 years’ experience validating laboratory instruments with computer systems.
• Experience with PR/CAPA systems preferred.

Responsibilities

• Provide validation expertise and support to Quality Control laboratories.
• Prepare validation deliverables and lead change control processes.
• Ensure compliance with regulatory guidelines.

Skills

FDA regulations

Data Integrity

cGMP

Risk assessments

Change control

Job description

Integrated Resources, Inc. is seeking a Quality Control Validation Specialist in Durham, NC. The ideal candidate must have expertise in validating laboratory instruments in a pharmaceutical setting, with a thorough understanding of FDA regulations and cGMP standards. This role involves developing validation documents, ensuring compliance, and leading risk assessments. Candidates should possess at least four years of relevant experience and demonstrate strong attention to detail in compliance with regulatory requirements.