Validation Engineer

Intellectt Inc; Greenville (NC); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Health Insurance (not specified)

401(k) retirement option

Paid time off as per state laws

Job summary

Intellectt Inc seeks a Validation Contractor to support QA oversight of CQV activities at a regulated manufacturing site in Greenville, NC. You will review qualification documents, ensure cGMP compliance, and support validations across facilities, equipment, utilities, cleaning procedures, and manufacturing processes.

Collaborate with Quality, Engineering, Validation, Manufacturing, MSAT, and QC teams to maintain inspection readiness and address compliance.

Qualifications

• Minimum of 7 years of experience in pharmaceutical or medical device industries.
• At least 5 years of hands-on experience in Engineering, Validation, or CQV.
• Strong understanding of cGMP requirements and regulations (21 CFR 210/211, 600, 820).
• Knowledge of ISO 13485, ISO 9001, and ICH Q9/Q10.
• Experience reviewing and approving qualification and validation protocols and reports.
• Experience with deviations, CAPAs, change controls, and regulatory inspections readiness.
• Familiarity with electronic quality management systems (Documentum, Veeva Vault, TrackWise).
• Strong analytical, troubleshooting, documentation, and communication skills.

Responsibilities

• Review, author, and approve URS, commissioning plans, IQ/OQ/PQ protocols and reports.
• Provide risk-based QA oversight for equipment qualification, CSV, cleaning validation, and process validation.
• Review APQRs and support maintenance of site VMPs.
• Provide QA validation expertise for deviations, CAPAs, and change controls.
• Collaborate with MSAT, Engineering, Manufacturing, Validation, QC, and Maintenance during FAT, SAT, and startup activities.
• Support internal/external audits and regulatory inspections as a Validation SME.
• Review executed validation packages and monitor KPIs and trends for compliance risks.
• Ensure quality records, SOPs, and manufacturing documentation are accurate and retained per cGMP.
• Identify opportunities to improve CQV processes and implement quality initiatives.
• Provide guidance and training to junior QA Validation specialists and cross-functional teams.

Skills

CQV experience

cGMP knowledge

Regulatory compliance

Documentation review

Cross-functional collaboration

Audit support

Deviations & CAPAs

Validation protocols review

Education

Bachelor's degree in Engineering or related field

Tools

Documentum

Veeva Vault

TrackWise

Job description

Title: Validation Contractor - Quality Assurance / CQV

Contract Duration: 6 Months

Start Date: ASAP

Pay range: 45-50/hr on W2

Industry: Pharmaceutical / Medical Device Manufacturing

Position Overview

Our client is seeking an experienced Validation Contractor to support Quality Assurance oversight of commissioning, qualification, and validation (CQV) activities at a regulated manufacturing site in Greenville, North Carolina.

This role is ideal for a quality-focused validation professional with strong experience reviewing and approving qualification documentation, ensuring cGMP compliance, and supporting validation activities across facilities, equipment, utilities, cleaning procedures, and manufacturing processes.

The successful candidate will work closely with Quality, Engineering, Validation, Manufacturing, MSAT, and QC teams to maintain inspection readiness, address compliance issues, and ensure validation programs meet regulatory and quality requirements.

Key Responsibilities

• Review, author, 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.
• Review Annual Product Quality Reviews (APQRs) and support the maintenance of site Validation Master Plans (VMPs).
• Provide Quality Validation expertise for deviations, CAPAs, and change controls related to facilities, utilities, equipment, and validation activities.
• Collaborate with MSAT, Engineering, Manufacturing, Validation, QC, and Maintenance teams during FAT, SAT, and facility startup activities.
• Support internal and external audits, client audits, and regulatory inspections as a Validation Quality subject matter expert.
• Review executed validation packages and monitor program performance, trends, KPIs, and potential compliance risks.
• Ensure quality records, SOPs, and manufacturing support documentation are accurate, complete, properly retained, and compliant with cGMP requirements.
• Identify opportunities to improve CQV processes and support the implementation of quality initiatives.
• Provide guidance and training to junior QA Validation specialists and cross-functional teams.

Required Qualifications

• Minimum of 7 years of experience in the pharmaceutical or medical device industry.
• At least 5 years of hands-on experience in Engineering, Validation, or CQV.
• Strong understanding of cGMP requirements and applicable regulations, including 21 CFR Parts 210/211, 600, and 820 (QMSR), as relevant to the facility and products.
• Knowledge of ISO 13485, ISO 9001, and ICH Q9/Q10.
• Proven experience reviewing and approving qualification and validation protocols, reports, and supporting documentation.
• Experience with deviations, CAPAs, change controls, and regulatory inspection readiness.
• Familiarity with electronic quality management and document management systems, such as Documentum, Veeva Vault, and TrackWise.
• Strong analytical, troubleshooting, documentation, and problem-solving skills.
• Excellent communication and collaboration skills, with the ability to work across multiple departments and organizational levels.

Education

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

Pay Scale-

Anticipated hourly pay range: specific range such as ($30/hr to $33/hr).

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