Validation Engineer

Katalyst-Healthcares-; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst-Healthcares- seeks a Validation Contractor to oversee CQV activities in a regulated pharma/medical device environment. The role ensures facilities, equipment, utilities, and processes meet cGMP and regulatory standards.

Responsibilities include reviewing URS and IQ/OQ/PQ documents, supporting CSV and validation activities, and contributing to audits and KPI reporting. Collaboration across MSAT, Engineering, Manufacturing, and QC is essential.

Qualifications

• 7+ years in pharma/medical device industries required.
• 5+ years hands-on CQV/engineering experience.
• Strong knowledge of 21 CFR Parts 210/211, 600, 820; ISO 13485/9001; ICH Q9/Q10.
• Proven ability to review qualification/validation protocols and reports.
• Experience supporting deviations, CAPAs, change controls and regulatory inspections.

Responsibilities

• Author/review/approve URS, IQ/OQ/PQ protocols and reports.
• Oversee equipment qualification, CSV, cleaning validation and process validation.
• Review APQRs and maintain site Validation Master Plans (VMPs).
• Serve as Quality Validation SME for deviations, CAPAs, change controls.
• Collaborate with MSAT, Validation, Engineering, Manufacturing and QC teams during FAT/SAT and startup activities.
• Support internal and external audits and regulatory inspections.

Skills

7+ years pharma/med device

CQV/engineering experience

Regulatory knowledge (21 CFR ISO etc)

Protocol review & IQ/OQ/PQ

CAPA/change controls

QMS software (Documentum/Veeva/TrackW)

Analytical/problem-solving

Cross-functional collaboration

Education

Bachelor's degree in engineering or related

Tools

Documentum

Veeva Vault

TrackWise

Job description

Our client is seeking a Validation Contractor to provide quality oversight of the Commissioning, Qualification, and Validation (CQV) program within a regulated pharmaceutical or medical device manufacturing environment. This individual will ensure facilities, equipment, utilities, cleaning procedures, and manufacturing processes remain compliant with applicable cGMP requirements and regulatory standards.

Key responsibilities include:

• Author, review, and approve User Requirements Specifications (URS), commissioning plans, and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
• Provide risk-based Quality oversight and approval 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 the Quality Validation subject matter expert for deviations, Corrective and Preventive Actions (CAPAs), and change controls associated with qualification, validation, facilities, and utilities.
• Collaborate with MSAT, Validation, Engineering, Manufacturing, Metrology/Maintenance, and QC teams during Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and facility start-up activities.
• Support internal and external audits, client audits, and regulatory inspections as a Validation Quality SME.
• Monitor and evaluate executed validation packages, track and trend program performance, identify compliance risks, and report key performance indicators (KPIs) to leadership.
• Review quality records, Standard Operating Procedures (SOPs), and manufacturing support documentation to ensure accuracy, completeness, proper record retention, and cGMP compliance.
• Identify opportunities for continuous improvement within the CQV program and support the implementation of quality initiatives.
• Provide guidance, training, and compliance support to junior QA Validation specialists and cross-functional teams.

Skills:

• Minimum of 7 years of experience within the pharmaceutical or medical device industry.
• Minimum of 5 years of hands-on Engineering, Validation, or Commissioning, Qualification, and Validation (CQV) experience.
• 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 such as Documentum, Veeva Vault, and TrackWise.
• Strong analytical, troubleshooting, and problem-solving skills within highly regulated manufacturing environments.
• Excellent communication, organizational, and interpersonal skills with the ability to collaborate across multiple departments and organizational levels.

Education:

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