GxP QA Engineer II - Validation & Compliance

Socket.dev; Durham (NC); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance (HDHP with HSA; PPO)

Dental Insurance

Vision Insurance

Flexible Spending Account (medical; de

Short Term Disability | Long Term

Paid Time Off (4 weeks/year)

Parental Leave

Paid Holidays (9 + 5)

401k with Employer Match

Employee Referral Program

Job summary

BioAgilytix in Durham, NC seeks a Quality Engineer II to provide QA oversight of computer validations and equipment qualifications, partnering with cross‑functional teams to meet business needs.

You will oversee validation activities (LIMS/ELN/QCBD), maintain QA systems, and ensure compliance with GxP regulations and 21 CFR Part 11. A bachelor’s degree and 5+ years in pharma are required, with strong documentation and communication skills.

Qualifications

• Bachelor’s degree in engineering, IT, CS, or related field required.
• Minimum five years’ experience in pharma/GxP/regulatory environment.
• Direct hands-on experience with computer systems validation and/or equipment qualifications.
• Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ISO).

Responsibilities

• Provides QA guidance in development and revision of computer system and equipment procedures and policies (validations, change control, security).
• Ensures activities related to computer systems and equipment qualifications comply with GxPs and regulatory parts.
• Performs quality review of SOPs, policies, and validation/equipment master plans.
• Oversees validation/qualification projects with cross‑functional teams (e.g., LIMS, ELN, QCBD, equipment software).
• Manages QA for Quality Management Systems (ZenQMS, Blue Mountain).
• Oversees electronic archives upkeep and validation status listings.
• Reviews and approves equipment out-of-tolerance investigations.
• Qualifies vendors/contractors for validation activities.
• Ensures periodic reviews and follow-up actions are completed.
• Approves validation documentation for new/existing systems/equipment.
• Reviews deviations/incidents and drives corrective actions.
• Acts as QA representative during IT testing and regulatory inspections.
• Reviews change controls and Out of Tolerances for timely closure.
• Performs duties with minimal QA engineer management oversight.
• Other duties as needed.

Skills

GxP knowledge

Computer system validation

Equipment qualification

QA oversight

LIMS

GAMP guidelines

Validation engineering

IT infrastructure

Documentation

Microsoft Office

Education

Bachelor’s degree in engineering, information technology, computer science, or related discipline

5+ years’ experience in pharmaceutical/GxP/regulated environment

Hands-on experience with computer systems validation and/or equipment qualifications

GxP regulations (FDA, EPA, EU, ICH, USP, ISO)

Tools

LIMS

QMS software (ZenQMS, Blue Mountain)

ELN

Microsoft Office

Job description

BioAgilytix in Durham, NC seeks a Quality Engineer II to provide QA oversight of computer validations and equipment qualifications, partnering with cross‑functional teams to meet business needs.

You will oversee validation activities (LIMS/ELN/QCBD), maintain QA systems, and ensure compliance with GxP regulations and 21 CFR Part 11. A bachelor’s degree and 5+ years in pharma are required, with strong documentation and communication skills.