Validation Engineer

Job Title: Validation Contractor Quality / CQV

Company: Novozen Health Care

Location: Raleigh, North Carolina

Employment Type: Contract (6 Months)

Job Responsibilities

• Provide Quality oversight of Commissioning, Qualification, and Validation (CQV) programs within regulated pharmaceutical or medical device manufacturing environments.

• Author, review, and approve User Requirements Specifications (URS), commissioning plans, and IQ/OQ/PQ protocols and reports.

• Provide risk-based Quality oversight for equipment qualification, Computerized System Validation (CSV), cleaning validation, and process validation activities.

• Review Annual Product Quality Reviews (APQRs) and maintain site Validation Master Plans (VMPs).

• Serve as a Quality Validation SME for deviations, CAPAs, and change controls related to qualification, validation, facilities, and utilities.

• Collaborate with MSAT, Validation, Engineering, Manufacturing, Metrology/Maintenance, and QC teams during FAT, SAT, and facility start-up activities.

• Support internal and external audits, client audits, and regulatory inspections as a Validation Quality SME.

• Monitor validation packages, track program performance, identify compliance risks, and report KPIs to leadership.

• Review quality records, SOPs, and manufacturing documentation to ensure accuracy, completeness, and cGMP compliance.

• Identify opportunities for continuous improvement and provide guidance and training to junior QA Validation specialists and cross-functional teams.

Required Qualifications

• Bachelor's degree in Engineering (Biomedical, Chemical, or Mechanical), Biology, Chemistry, Pharmacy, or a related scientific discipline.

• Minimum of 7 years of experience in the pharmaceutical or medical device industry.

• Minimum of 5 years of hands-on Engineering, Validation, or CQV experience.

• Strong knowledge of 21 CFR Parts 210/211, 600, and 820 (QMSR), ISO 13485, ISO 9001, and ICH Q9/Q10.

• Demonstrated experience reviewing and approving qualification and validation protocols, reports, and supporting documentation.

• Experience supporting deviations, CAPAs, change controls, and regulatory inspection readiness.

• Proficiency with electronic quality management systems such as Documentum, Veeva Vault, and TrackWise.

• Strong analytical, troubleshooting, problem-solving, communication, and organizational skills.

• Ability to collaborate effectively across multiple departments and organizational levels.

• Ability to provide managerial references is required.

Pay Scale

Anticipated hourly pay range$40 $45 per hour on W-2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.

Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.