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.
Soft Skills & Competencies
- 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.
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Skills Required
- Equipment and packaging characterization experience
- Experience defining operational parameters and ranges for assembly machines, cartoners, carton labelers, case packers, palletizers, accumulators, and labeling systems
- Working knowledge of FDA 21 CFR Part 4, 21 CFR 211, 21 CFR 820 and ISO 13485
- Experience with physical characterization techniques assessing mechanical testing, temperature variation, applied forces, and light exposure on materials
- Experience applying Design of Experiments (DOE), Minitab, data analysis, and edge-of-failure testing methodologies
- Ability to develop technical reports, protocols, executive summaries, and documentation based on engineering data
- Strong systems-thinking 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
- Flexibility to support first, second, or third shift operations as required
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
