Senior Packaging CQV Engineer

Pinnaql; South Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group Inc V&EG a Pinnaql company seeks a Senior CQV Packaging Validation Engineer to lead qualification and validation for a new packaging line handling liquids in multiple bottle and cap configurations.

The role requires coordinating with validation, engineering, manufacturing and quality, ensuring adherence to cGMP and FDA guidelines while supporting related facilities utilities validation as needed. On-site work is required.

Qualifications

• Bachelor's degree in Engineering or Natural Sciences preferred.
• Minimum 6 years of experience in CQV/validation in GMP environment.
• Hands-on Kneat experience is required.
• Familiarity with ValGenesis, Veeva Vault, or Validation MasterControl and ability to ramp up on Kneat.
• Demonstrated leadership in validation or engineering roles.
• Excellent written and verbal communication; able to coordinate across departments.

Responsibilities

• Lead and execute qualification and validation activities for packaging systems (fillers, cappers, labelers, conveyors, vision, serialization).
• Coordinate validation priorities, sequencing, and deliverables with stakeholders.
• Act as the validation point of contact for the packaging line; report status, risks, and issues.
• Prepare and execute validation documentation (IQ/OQ/PQ, FAT, risk assessments, etc.).
• Support validation for facilities utilities and solution preparation systems as needed.
• Perform FAT at vendor/OEM sites including international locations; resolve punch lists.
• Provide hands-on support during commissioning and qualification activities on the floor.
• Validate change parts and line configurations for different bottle/cap configurations.
• Drive deviations, root-cause analysis, and documentation updates.

Skills

Kneat

Packaging validation

CQV

GMP

IQOQPQ

Validation lifecycle

Equipment qualification

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 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 FATSAT protocols IQOQPQ 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

• Bachelors 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 eg 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 IQOQPQ 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 isnt just a job its 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.

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.