Characterization Process Development Specialist

Veg Group; New Albany (OH); On-site; USD 85,000 - 125,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) seeks a Characterization Process Development Specialist to optimize equipment and packaging characterization within pharmaceutical, biotech, and medical device contexts.

You will work across Engineering, Quality, Packaging Engineering, and Manufacturing teams, applying DOE, statistical analysis, and material science to develop clear reports, protocols, and documentation, while ensuring CGMP compliance and effective data-driven decisions.

Qualifications

• Experience with FDA 21 CFR Part 4 and CGMP regulations.

Responsibilities

• Characterize equipment and packaging processes.
• Define operating parameters and ranges for assembly machines and packaging lines, optimizing performance.
• Develop technical reports, protocols, executive summaries, and documentation based on engineering data.
• Collaborate across Engineering, Quality, Packaging Engineering, and Manufacturing teams to drive process improvements.

Skills

DOE

Statistical Analysis

Analytical & Material Science

Root Cause Analysis

Technical Writing

Cross-functional Collaboration

Communication Skills

English Proficiency

Tools

Minitab

Job description

Current job opportunities are posted here as they become available.

Characterization Process Development Specialist

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:

• Characterization Process Development Specialist

Technical Requirements

• Equipment & Packaging Characterization
• Experience defining operational parameters and ranges for assembly machines, cartoners, carton labelers, case packers, palletizers, accumulators, and labeling systems, while optimizing equipment performance.

Combination Product Regulations

• Working knowledge of FDA 21 CFR Part 4 requirements, including CGMP regulations under 21 CFR 211 and 21 CFR 820 / ISO 13485.
• Analytical & Material Science
• Experience with physical characterization techniques and evaluating the effects of mechanical testing, temperature variation, applied forces, and light exposure on materials.
• Statistical Analysis & DOE
• Experience applying Design of Experiments (DOE), Minitab, data analysis, and edge-of-failure testing methodologies.
• Technical Writing
• Ability to develop clear technical reports, protocols, executive summaries, and documentation based on engineering data.
• Strong systems-thinking abilities and understanding of packaging line interactions.
• Root cause analysis and problem-solving skills.
• Ability to work effectively across Engineering, Quality, Packaging Engineering, and Manufacturing teams.
• Strong organizational skills in fast-paced environments.
• Excellent verbal and written communication skills.
• Professional fluency in English (written and spoken).
• Flexibility to support first, second, or third shift operations as required.

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.

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.