Ecocareers ยท 23 hours ago
Validation Engineer
Holly Springs, NC
Full-time
Onsite
Senior LevelConfidential company is seeking a Senior CQV Engineer who will lead and execute Commissioning, Qualification, and Validation (CQV) activities for Clean-In-Place systems in Drug Substance Manufacturing. The role requires collaboration with cross-functional teams to ensure compliance with regulatory and quality standards.
Staffing & Recruiting
Responsibilities
Lead and execute commissioning, qualification, and validation activities for CIP systems supporting Drug Substance manufacturing operations
Author, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities
Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports
Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst-case conditions
Act as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria
Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing
Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria
Support residue, bioburden, and TOC sampling strategies as part of cleaning validation
Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations
Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance
Provide validation support during tech transfers, process changes, and new equipment installations
Ensure all CQV and cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements
Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation
Support internal and external audits and regulatory inspections
Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams
Provide guidance and mentoring to junior CQV engineers and validation resources as needed
Qualification
Required
Hands-on experience in CIP system design review, qualification execution, and cleaning validation strategy
Ability to work independently in a fast-paced manufacturing environment
Collaboration skills with Engineering, Manufacturing, Quality, and Automation teams
Lead and execute commissioning, qualification, and validation activities for CIP systems
Author, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities
Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports
Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst-case conditions
Act as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria
Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing
Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria
Support residue, bioburden, and TOC sampling strategies as part of cleaning validation
Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations
Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance
Provide validation support during tech transfers, process changes, and new equipment installations
Ensure all CQV and cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements
Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation
Support internal and external audits and regulatory inspections
Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams
Provide guidance and mentoring to junior CQV engineers and validation resources as needed
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase