Principal Product Development Engineer
Job in
Mooresville, Iredell County, North Carolina, 28115, USA
Listed on 2026-08-22
Listing for:
SCN BestCo
Full Time
position Listed on 2026-08-22
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Essential Duties And Responsibilities
- Seek and evaluate new ingredients and technologies in pursuit of developing unique product offerings in confectionary OTC and supplement markets, engaging suppliers/vendors, and translating insights into scalable development strategies.
- Translate product briefs and consumer needs into formulation strategies that meet dose targets, sensory attributes, and manufacturability requirements.
- Prepare product samples, test, and analyze physical and sensory attributes (e.g., texture, moisture, pH, and color) against defined acceptance criteria, and link results to stability and scale‑up decisions to develop a comprehensive data package.
- Execute Design of Experiments (DOEs) to identify critical drivers (critical process parameters and critical quality attributes; CPP/CQA), define robust parameter windows, and improve scale-up repeatability with clear analysis recommendations.
- Develop strategic partnerships with external industry leaders and internal stakeholders to generate scalable opportunities for product platforms, informing portfolio decisions and manufacturability.
- Engage with cross functional teams including quality, procurement, supply chain, manufacturing, regulatory, and commercial to resolve development and improvement issues, align translation standards (bench/pilot representativeness, sampling), and drive commercialization readiness.
- Establish and maintain soft‑chew CPP/CQA strategy across programs, including selection rationale, parameter window development, monitoring requirements, and capability expectations (e.g., variance analysis, and process capability/performance index [Cpk/Ppk] where applicable).
- Set and approve validation standards and acceptance criteria across lifecycle stages and ensure continued process verification (CPV) expectations are met in partnership with Operations/Quality.
- Define and govern phase‑/stage‑gate technical standards (deliverables, acceptance criteria, escalation triggers) and audit Gate readiness across programs to ensure disciplined decisions and resource allocation.
- Own product stability strategy (risk assessment, study design, acceptance criteria, interpretation) to ensure stability evidence supports scale‑up decisions and commercialization readiness.
- Support knowledge capture and organizational knowledge growth via effective data summaries, reports, and presentations.
- Mentor peers and junior scientists on best practices and product knowledge.
- Define and drive best practices; recommend paths going forward; govern change control rigor and document accuracy; lead risk management by setting criteria, reviewing risk matrices, and executing mitigations/escalations; ensure alignment across multiple teams.
- Actively supervise, hire, train, schedule, coach, and develop assigned employees.
- Provide task direction to team members and On the Job Training (OJT) for new hires (Onboarding).
- Listen to team members' feedback and resolve/report any issues or conflicts.
- Conduct performance reviews and manage individual performance.
- Recommend personnel actions (pay adjustments, promotions, transfers, terminations).
- Communicate personnel actions following Human Resources and Department Head approval.
- Ensure safety and quality standards are enforced and met.
- Bachelor’s degree in a pharmaceutical science, chemical engineering, food science, chemistry, or related scientific discipline.
- 10 years’ experience in product development engineering, science, or similar function.
- Experience applying statistical analysis, mathematical modeling, machine learning, data mining, and related techniques to drive solutions.
- Proficient with Microsoft Office and database, project management and ERP software, as well as PLM/documentation stage‑gate tools and statistical/visualization software (e.g., DOE/analysis platforms) used to support evidence‑based decisions.
- Thorough knowledge of confectionary manufacturing and ingredients.
- Working knowledge of cGMP and Good Laboratory Practices (GLP), with strong documentation discipline, change‑control rigor, and the ability to…
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