What are the responsibilities and job description for the CQV Enginner - Packaging Validation Specialist - Pharma - Biotech - SC position at Pharma Resource Group, Inc.?
Commissioning, Qualification & Validation Specialist - Packaging
- Location: Greenville, SC
- Type: On-site, Contract
Description:
Summary:
We are seeking a CQV / Packaging Validation Specialist to support qualification and validation activities for a new packaging line handling liquid products in multiple bottle and cap configurations.
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:
- Execute equipment qualification and validation activities primarily for packaging systems, including fillers, cappers, labelers, conveyors, vision systems, and serialization systems.
- Support qualification and validation activities for facilities, utilities, and solution preparation systems as required.
- Develop and execute validation documentation, including risk assessments, FAT/SAT protocols, IQ/OQ/PQ, and summary reports.
- 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.
- Assist with deviation resolution and documentation updates during validation execution.
- Ensure all validation deliverables comply with cGMP, FDA regulations, and site procedures.
- Collaborate with validation, engineering, manufacturing, and quality teams to support timely project execution.
Qualifications:
- Bachelor’s degree in Engineering or Natural Sciences preferred.
- Minimum 3–5 years of experience supporting CQV or validation activities in a GMP-regulated environment.
- Experience with IQ/OQ/PQ protocol development and execution.
- Kneat experience strongly preferred.
- Packaging validation experience preferred; however, strong equipment CQV experience in pharmaceutical or biotechnology manufacturing will be considered.
- Working knowledge of cGMP requirements and regulatory expectations.
- Strong documentation, organization, and communication skills.
- Ability to work on-site in a fast-paced manufacturing environment.
Job Types: Full-time, Contract
Benefits:
- Health insurance
- Paid time off
Work Location: In person