Bachelor's degree in Engineering or Natural Sciences preferred.
Minimum 6 years of experience in CQV or validation in a GMP-regulated environment.
Hands-on experience with Kneat or similar electronic validation platforms.
Demonstrated leadership in validation or engineering roles.
Excellent communication skills for cross-department coordination.
Experience with IQ/OQ/PQ protocol development and execution.
Packaging validation experience preferred, but strong CQV experience in pharma/biotech is acceptable.
Strong documentation and organizational skills.
Ability to work on-site in a fast-paced environment.
Willingness to travel internationally for FAT activities.
Responsibilities
Lead and execute qualification and validation for packaging systems.
Coordinate validation activities, ensuring alignment on priorities and timelines.
Act as the validation contact for the packaging line, communicating status and risks.
Author and review validation documentation in Kneat, including risk assessments and protocols.
Support qualification for facilities, utilities, and solution preparation systems as needed.
Execute FAT activities at vendor facilities and resolve punch-list items.
Provide hands-on support during commissioning and qualification on the manufacturing floor.
Support qualification of change parts and line configurations for different presentations.
Drive deviation resolution and documentation updates during validation execution.
Ensure compliance with cGMP, FDA regulations, and site procedures.
Benefits
Opportunity to lead critical validation projects in a dynamic environment.
Collaborative work culture with cross-functional teams.
Hands-on involvement in cutting-edge packaging technologies.
Potential for international travel and exposure to global operations.
Professional development opportunities in validation and engineering.
Full Job Description
Senior Packaging CQV Engineer
Summary: We are seeking a Senior CQV / Packaging Validation Engineer to lead qualification and validation activities for a new packaging line handling liquid products in multiple bottle and cap configurations. This role requires a team member who can operate independently and serve as the primary point of coordination between validation, engineering, manufacturing, and quality.
While the primary focus will be packaging systems, this role may also support validation activities related to facilities, utilities, and solution preparation systems as needed. The selected candidate must be flexible and able to adapt to evolving project priorities.
Responsibilities:
Lead and execute equipment qualification and validation activities primarily for packaging systems, including fillers, cappers, labelers, conveyors, vision systems, and serialization systems.
Coordinate validation activities, ensuring alignment on priorities, sequencing, and deliverable timing.
Serve as the validation point of contact for the packaging line, communicating status, risks, and issues clearly to the Validation Manager and stakeholders at all levels.
Author, review, approve, and execute validation documentation in Kneat, including risk assessments, FAT/SAT protocols, IQ/OQ/PQ, and summary reports.
Support qualification and validation activities for facilities, utilities, and solution preparation systems as required.
Execute FAT activities at vendor/OEM facilities, including international sites, and drive resolution of punch-list items prior to shipment.
Provide hands-on support during commissioning and qualification activities on the manufacturing floor.
Support qualification of change parts and line configuration adjustments for different bottle and cap presentations.
Drive deviation resolution, root cause investigation, and documentation updates during validation execution, coordinating cross-functional input as needed.
Ensure all validation deliverables comply with cGMP, FDA regulations, and site procedures.
Qualifications:
Bachelor's degree in Engineering or Natural Sciences preferred.
Minimum 6 years of experience supporting CQV or validation activities in a GMP-regulated environment.
Hands-on Kneat experience is required. Candidates with demonstrated proficiency in a comparable electronic validation lifecycle management platform (e.g., ValGenesis, Veeva Vault Validation, MasterControl) and the ability to ramp up quickly on Kneat will also be considered.
Demonstrated leadership experience in a validation or engineering capacity.
Excellent written and verbal communication skills, with a proven ability to coordinate and align work across different departments.
Experience with IQ/OQ/PQ protocol development and execution.
Packaging validation experience strongly preferred; however, strong equipment CQV experience in pharmaceutical or biotechnology manufacturing will be considered.
Strong documentation and organizational skills.
Ability to work on-site in a fast-paced manufacturing environment.
Able to travel internationally for FAT execution activities, including valid passport or ability to obtain one.
