CQV Validation Area Specialists

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

Job Description

Job Description

CQV / Validation Area Specialists - 6 Positions

Reference: JQRI26SEP002

BaryCon is seeking six senior validation resources to lead CQV and validation activities across multiple pharmaceutical capital projects in Clayton, North Carolina. Assignments may cover facility systems, aseptic formulation and filling, device assembly and packaging, IT and automation systems, warehouse operations, and quality-control facilities.

ASSIGNMENT DETAILS

• - Full-time contract assignments; six positions.
• - 100% onsite in Clayton, NC, Monday-Friday, 8:00 AM-5:00 PM.
• - Anticipated start: December 1, 2026.
• - Duration: 24 months, with possible extensions based on performance.
• - Annual compensation: $80,000-$105,000 plus medical insurance, retirement and paid time off, based on experience and engagement structure.
• - Overtime: pre-approved only; paid at the agreed straight-time rate.
• - No per diem; local candidates preferred; 0% planned travel.
• - Background check and client onboarding required.

KEY 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.

PREFERRED INDUSTRY EXPERIENCE

• - Aseptic formulation and filling equipment, including Restricted Access Barrier Systems (RABS).
• - Vision inspection, medical-device assembly, and packaging equipment.
• - Process-control and manufacturing-execution systems such as SCADA, PLC, PAS-X, and LMES.
• - Laboratory and GMP facility modifications, warehouse systems, and quality-control environments.
• - Process instrumentation, monitoring and calibration systems.
• - BMS, HVAC, refrigeration, facility utilities, electrical distribution, switchgear, and controls.
• - Physical security, access control, CCTV, and technology lifecycle or modernization projects.

REQUIRED SKILLS / QUALIFICATIONS

• - Senior-level experience generating and executing validation documentation in a pharmaceutical environment.
• - Ability to independently complete deliverables after the onboarding and training period.
• - Working knowledge of GMP, FDA expectations, EU Annex 15, GAMP 5, and applicable company procedures.
• - Experience with electronic quality and validation systems such as TIMS/HP ALM, Veeva QualityDocs, or Vault Quality is beneficial.
• - Strong technical writing, investigation, risk-assessment, project coordination, and stakeholder communication skills.
• - Ability to manage multiple projects of varying size and complexity while maintaining schedule and documentation quality.

WORKING EXPECTATIONS

Resources will work with multiple project managers and provide regular status updates. On larger projects or during plant shutdowns, pre-approved evening or weekend work may be required.

ABOUT BARYCON

BaryCon supports leading pharmaceutical companies with engineering oversight, project management, CQV execution, validation, BIM/VDC services, and technical consulting across the U.S. and Europe.

Company Description

BaryCon is a leading Global provider of professional engineering and project management services, specializing in the construction and pharmaceutical industries. We focus on delivering innovative, high-quality solutions for our clients while fostering a collaborative and supportive work environment. With a commitment to integrity, safety, and growth, BaryCon offers employees opportunities to advance their careers within a rapidly expanding organization.