Validation Engineer - CQV

TekHawks; Greenville (NC); Sur place; USD 96 000 - 165 000; Plein temps

Résumé du poste

Tekhawks LLC. seeks a Validation Contractor to oversee CQV programs within a regulated pharmaceutical/medical device environment. You will ensure facilities, equipment, utilities, cleaning procedures, and manufacturing processes stay compliant with cGMP and regulatory standards.

Your role includes authoring and approving URS, IQ/OQ/PQ protocols, reviewing APQRs, maintaining VMPs, and supporting audits. Collaboration across MSAT, Validation, Engineering, and QC is essential to success.

Qualifications

• Minimum of 7 years of experience in the pharmaceutical or medical device industry.
• Minimum of 5 years hands-on Engineering, Validation, or CQV experience.
• Strong working knowledge of 21 CFR Parts 210/211, 600, and 820; ISO 13485/9001; ICH Q9/Q10.
• Experience reviewing qualification/validation protocols, reports, and supporting documentation.
• Experience supporting deviations, CAPAs, change controls, and regulatory inspection readiness.
• Proficiency with electronic quality management systems (e.g., Documentum, Veeva Vault, TrackWise).
• Excellent communication, organizational, and interpersonal skills.

Responsabilités

• Author, review, and approve URS, IQ/OQ/PQ protocols and reports.
• Provide QA validation oversight for CSV, cleaning validation, and process validation activities.
• Review APQRs and maintain site VMPs.
• Serve as Validation SME for deviations, CAPAs, and change controls.
• Collaborate with MSAT, Validation, Engineering, Manufacturing, and QC teams during FAT/SAT and start-up.
• Support audits and regulatory inspections as Validation SME.
• Monitor and report KPIs and validation package performance.
• Review SOPs and records for cGMP compliance.

Connaissances

CQV experience

cGMP knowledge

Regulatory readiness

Quality systems

Cross-functional collaboration

Formation

Bachelor's degree in Engineering

Outils

Documentum

Veeva Vault

TrackWise

Description du poste

Duration: 6+ Months with a high possibility of extension

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.