Characterization Process Development Specialist

Pinnaql; New Albany (OH); On-site; USD 80,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Characterization Process Development Specialist to lead equipment characterization and process development for packaging and assembly systems. The role emphasizes DOE, data analysis, and strong cross-functional collaboration to optimize performance.

The ideal candidate will develop clear technical reports and documentation, support QMS requirements, and adapt to a fast-paced environment with shift flexibility as needed.

Qualifications

• Experience defining operational parameters for packaging/assembly equipment.
• Proficiency in statistical analysis and DOE methodologies.
• Ability to develop clear technical reports, protocols and summaries based on data.
• Strong cross-functional collaboration across Engineering, Quality, Packaging Engineering, and Manufacturing.
• Flexibility to support first/second/third shift operations as required.

Responsibilities

• Define operational parameters and ranges for packaging lines and equipment to optimize performance.
• Characterize equipment and processes; evaluate effects of mechanical testing, temperature, forces, and light exposure on materials.
• Analyze data, perform DOE and root cause analysis, and report findings with clear documentation.
• Collaborate with Engineering, Quality, Packaging Engineering, and Manufacturing teams to drive improvements.
• Develop technical reports, protocols, and executive summaries from engineering data.

Skills

Equipment characterization

DOE

Minitab

Data analysis

Root cause analysis

Tools

Minitab

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:

• 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.

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.