Validation Engineer

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

IRI believes in commitment, integrity, and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with decades of industry experience. We deliver strategic workforce solutions that help manage talent and business efficiently. Since 1996, IRI has attracted and retained experts in various fields, expanding into new sectors and growing steadily.

We focus on finding qualified professionals in our specialty areas. Our partner-employers trust us to match their needs with top-tier candidates. By exceeding expectations, we build long-term partnerships rooted in performance and integrity.

Our team provides tailored approaches for each client, matching the right employers with the right candidates and aligning skills with company cultures. At IRI, our success depends on our clients' success.

Job Description

· Experience in a sterile or pharmaceutical environment is required; consideration will be given to candidates with FDA -- cGMP experience or in medical device or combination product production.

· Validated Quality Control laboratory instruments (with or without computer systems) according to site SOPs.

· Prepare validation deliverables as required.

· Ensure systems are installed and configured in compliance with 21 CFR Part 11/Annex 11.

· Provide validation expertise and support to Quality Control laboratories.

· Minimum 4 years’ experience validating equipment.

· Minimum 2 years’ experience validating laboratory instruments with computer systems.

· Lead change control processes for new or modified instruments and software in Quality Control labs.

· Develop validation documents including risk assessments, user requirements, validation plans, protocols (IQ, OQ, PQ), reports, and addendums per site SOPs. Experience with laboratory instrument system validation is preferred.

· Review validation deliverables from others for compliance and approve as needed.

· Assist in evaluating user roles, privileges, and maintenance instructions to ensure data integrity.

· Conduct periodic reviews focusing on change control, deviations, and CAPA to maintain compliance and validated state.

· Experience with PR/CAPA systems is preferred.

· Ensure adherence to regulatory guidelines on Electronic Records, Signatures, Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, and MHRA. Develop protocols to demonstrate compliance and address gaps.

· Lead risk assessments, gap analyses, and deviation management related to lab instrument validation.

· Support team members and perform other duties as assigned.

· Act as Subject Matter Expert, System Owner, and System Super User for laboratory instruments as applicable.

· Oversee instrument calibration activities.