Senior Packaging CQV Engineer

Pinnaql; Greenville (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in Greenville, SC is seeking a Senior CQV / Packaging Validation Engineer to lead qualification and validation activities for a new packaging line handling liquid products.

You will coordinate between validation, engineering, manufacturing, and quality, while independently driving project priorities on-site. The role emphasizes packaging systems, with flexibility to support facilities and utilities validation as needed.

Qualifications

• Requires a Bachelor's degree in Engineering or Natural Sciences.
• Minimum 6 years of experience supporting CQV or validation in GMP settings.
• Hands-on Kneat experience is required; proficiency with similar platforms is a plus.
• Demonstrated leadership in validation or engineering roles.
• Strong written and verbal communication and cross-functional coordination.

Responsibilities

• Lead and execute equipment qualification and validation activities for packaging systems (fillers, cappers, labelers, conveyors, vision, serialization).
• Coordinate validation priorities, sequencing, and deliverable timing with stakeholders.
• Serve as the validation point of contact for the packaging line; report status, risks, and issues.
• Author, review, approve, and execute validation docs in Kneat (IQ/OQ/PQ, FAT/SAT, risk assessments, summaries).
• Support validation activities for facilities, utilities, and solution prep systems as needed.
• Perform FAT at vendor/OEM sites, including international sites; close punch-list items prior to shipment.
• Provide hands-on support during commissioning and qualification on the manufacturing floor.
• Drive deviation resolution and root cause investigations; update docs accordingly.
• Ensure all deliverables comply with cGMP, FDA regulations, and site procedures.

Skills

Leadership experience

Excellent written and verbal沟通

Education

Bachelor's degree in Engineering or Natural Sciences

Tools

Kneat

ValGenesis

Veeva Vault Validation

MasterControl

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.