AT01-102725 Packaging Validation Engineer SC
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Job Location:
Greenville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
30-10-2025
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) 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 ethics standards for the following position:
- Packaging Validation Engineer
- Location: Greenville SC
- Type: Contract / On-site
Summary:
We are seeking a Packaging Validation Engineer with strong leadership and communication skills to lead packaging qualification and validation efforts for sterile liquid filling and packaging operations in Greenville SC. The selected professional will coordinate and execute all CQV activities related to a new packaging line handling liquid products in multiple bottle and cap configurations working closely with client engineering manufacturing and quality teams to ensure project success and regulatory compliance.
Responsibilities:
- Lead the packaging validation project coordinating cross-functional efforts and ensuring alignment with project objectives timelines and regulatory requirements.
- Develop and execute validation documentation (URS risk assessments FAT/SAT IQ/OQ/PQ and final reports) for packaging lines and related equipment including fillers cappers labelers conveyors vision inspection and serialization systems.
- Manage communication between validation engineering and quality teams to drive efficient decision-making and issue resolution.
- Oversee qualification of change parts line configuration changes and multiple bottle/cap presentations.
- Provide hands-on support during commissioning and execution phases including troubleshooting and deviation resolution.
- Support process performance qualification (PPQ) activities and readiness for commercial production.
- Ensure all validation deliverables comply with cGMP FDA and EU Annex 1 requirements as well as internal procedures and the sites Validation Master Plan (VMP).
Qualifications:
- Bachelors degree in Engineering or Natural Sciences.
- Experience in packaging validation for sterile or aseptic liquid operations.
- Demonstrated experience leading validation projects or small technical teams.
- Solid understanding of liquid filling systems packaging automation inspection technologies and capping mechanisms.
- Strong knowledge of GAMP 5 21 CFR Part 11 and Annex 1.
- Excellent communication organization and documentation skills with the ability to effectively interact with clients peers and management.
- Ability to work independently and manage multiple priorities in a fast-paced regulated environment.
Preferred Skills:
- Experience leading packaging validation for sterile liquids or biologics.
- Familiarity with serialization and aggregation systems.
- Previous client-facing or project leadership experience within pharmaceutical or biotechnology manufacturing.
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
