Senior CQV Validation Lead - Onsite (Clayton, NC)

BaryCon INC.; Clayton (NC); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Retirement plan

Paid time off

Job summary

BaryCon leads CQV and validation activities across pharmaceutical capital projects in Clayton, North Carolina. Six senior validation resources are needed to cover facility systems, aseptic filling, device assembly, IT systems, warehouses, and QC facilities.

Assignments are 100% onsite, 8:00 AM-5:00 PM, starting December 1, 2026, for 24 months with possible extensions. Compensation ranges from $80,000 to $105,000 annually, plus medical insurance, retirement and PTO, based on experience.

Qualifications

• Senior-level experience generating and executing validation documentation in a pharmaceutical environment.
• Ability to independently complete deliverables after onboarding and training.
• Working knowledge of GMP, FDA expectations, EU Annex 15, GAMP 5, and company procedures.

Responsibilities

• Lead validation activities for assigned projects from requirements definition through decommissioning, as applicable.
• Develop and maintain validation plans and reports, specifications, risk assessments, traceability matrices, and decommissioning documentation.
• Author and execute Design Review/Qualification, IQ, OQ, PQ, and process-validation protocols and reports.
• Support commissioning and qualification activities and attend FATs when required by the project.
• Track deliverables and provide routine status, risk, and escalation updates to assigned project managers.
• Investigate deviations and engineering changes and support or author change controls and validation-impact assessments.

Skills

Senior-level validation experience

GMP / FDA / EU Annex 15 knowledge

Technical writing

Risk assessment

Project coordination

Stakeholder communication

Tools

TIMS/HP ALM

Veeva QualityDocs

Vault Quality

Job description

BaryCon leads CQV and validation activities across pharmaceutical capital projects in Clayton, North Carolina. Six senior validation resources are needed to cover facility systems, aseptic filling, device assembly, IT systems, warehouses, and QC facilities.

Assignments are 100% onsite, 8:00 AM-5:00 PM, starting December 1, 2026, for 24 months with possible extensions. Compensation ranges from $80,000 to $105,000 annually, plus medical insurance, retirement and PTO, based on experience.