Validation Contractor

Novozen Healthcare LLC; North Carolina; On-site; USD 59,000 - 62,000; Full time

Benefits offered by this job

Health Insurance

Retirement Benefits

PTO: Paid Time Off as per law

Job summary

Novozen Healthcare LLC seeks a senior CQV quality lead in North Carolina to provide quality oversight of CQV programs in regulated pharmaceutical and medical device environments.

You will review URS, commissioning plans, IQ/OQ/PQ protocols, and reports, while overseeing validation activities and CAPA management. Strong regulatory knowledge and cross-functional collaboration are essential.

You will mentor junior staff, support audits, and drive continuous improvement in validation practices.

Qualifications

• Minimum 7 years in pharmaceutical or medical device industry.
• Minimum 5 years in Engineering, Validation, or CQV.
• Strong knowledge of 21 CFR Parts 210/211, 600, 820; ISO 13485/9001; ICH Q9/Q10.
• Experience reviewing qualification protocols, reports, and docs.
• Experience supporting deviations, CAPAs, change controls, inspections.
• Proficiency with eQMS: Documentum, Veeva Vault, TrackWise.

Responsibilities

• Provide quality oversight of CQV programs in regulated environments.
• Review URS, commissioning plans, IQ/OQ/PQ protocols and reports.
• Oversee equipment qualification, CSV, cleaning and process validation.
• Review APQRs and maintain Validation Master Plans (VMPs).
• Manage deviations, CAPAs, and change controls.
• Collaborate with cross-functional teams during FAT/SAT and start-up.
• Support audits, regulatory inspections, and cGMP initiatives.
• Monitor validation activities, identify compliance risks, report KPIs.
• Review SOPs and manufacturing documentation; train junior staff.

Skills

CQV expertise

Regulatory compliance

Cross-functional collab

Analytical skills

Communication skills

Tools

Documentum

Veeva Vault

TrackWise

Job description

• Provide Quality oversight of CQV programs in regulated pharmaceutical and medical device manufacturing environments.
• Review and approve URS, commissioning plans, IQ/OQ/PQ protocols, and reports.
• Oversee equipment qualification, CSV, cleaning validation, and process validation.
• Review APQRs and maintain Validation Master Plans (VMPs).
• Manage quality-related deviations, CAPAs, and change controls.
• Collaborate with cross-functional teams during FAT, SAT, and facility start-up activities.
• Support audits, regulatory inspections, and cGMP compliance initiatives.
• Monitor validation activities, identify compliance risks, and report KPIs.
• Review SOPs, quality records, and manufacturing documentation.
• Drive continuous improvement and provide validation guidance and training to junior team members.

Required Qualifications:

• Minimum of 7 years of experience in the pharmaceutical or medical device industry.
• Minimum of 5 years of hands‑on experience in Engineering, Validation, or Commissioning, Qualification, and Validation (CQV).
• Strong working 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 (eQMS), including Documentum, Veeva Vault, and TrackWise.
• Strong analytical, troubleshooting, and problem‑solving skills in regulated manufacturing environments.
• Excellent communication, organizational, and interpersonal skills.
• Ability to collaborate effectively across multiple departments and organizational levels.

Pay Scale

Anticipated hourly pay range: $43/hr to $45/hr (W2).

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.