Description
Summary
The Senior Process Engineer is considered a subject matter expert (SME) and is responsible for ensuring packaging and production efficiencies, identifying operational problems, and developing solutions to achieve objectives such as cost savings and improved efficiency. This role is a key contributor to Technical Operations by gathering data during production runs, making time-sensitive decisions, and driving continuous process improvements.
Responsibilities
Manage change across the supply chain and identify solutions through simplification and standardization of processes.
Identify risks and implement mitigation strategies through emerging technologies and process improvements.
Apply strong engineering fundamentals, including Design of Experiments (DOE) and statistical data analysis.
Lead problem-solving sessions using lean manufacturing methodologies (A3).
Investigate and determine root causes for assigned consumer complaints.
Support operations by assisting troubleshooting efforts and leading process optimization projects.
Create and update Bills of Operations (BOO) for newly qualified formulas.
Build and maintain networks across industries to identify and implement emerging technologies.
Define critical process parameters for new equipment design and execute IOQ/PQ for new equipment and processes.
Assess commercial feasibility of concepts, recommend capital projects, and identify risks and solutions.
Collaborate with R&D, Operations, and Engineering teams through the Technology Transfer process to ensure reliable product lifecycle performance.
Review and manage consumer complaint trends, root cause analyses, and corrective actions.
Lead or assist in packaging component qualifications and optimization.
Manage packaging deviations and change requests.
Lead Factory Acceptance Tests (FATs) for new packaging/production equipment, create and revise Work Instructions (WIs), and provide training.
Perform timely adjustments to optimize production and packaging processes.
Lead pilot and first-time packaging runs, ensuring scope compliance and proper communication of changes.
Work closely with management and engineering to analyze processes and implement improvements.
Follow safety protocols and best practices to maintain a safe working environment.
Perform additional duties as assigned.
Supervisory Responsibilities
Yes, supervisory responsibilities
Requirements
Minimum Qualifications
Education/Knowledge
Bachelor’s degree in chemistry, biochemistry, food science, or a related field.
Lean Green Belt Certification (required within one year of employment).
Experience with structured problem-solving and process improvement.
Strong project planning and management skills with the ability to lead multiple projects.
Detail-oriented, data-driven, process-focused, and committed to teamwork and operational excellence.
Project Management Certification is a plus.
Experience
7+ years of experience in engineering, process development, quality, or related fields, preferably in pharmaceutical, dietary supplement, or food industries.
Proven ability to work collaboratively in fast-paced environments while maintaining safety.
Experience using physical testing equipment (scales, calipers, etc.).
Strong organizational skills and ability to manage multiple priorities.
Familiarity with Good Manufacturing Practices (cGMP), ERP systems (e.g., SAP), Work Instructions (WIs), Standard Operating Procedures (SOPs), and Batch Records.
Skills & Abilities
Data analysis and problem solving
Planning and organizing
Strong verbal and written communication
Relationship management and teamwork
Quality orientation and attention to detail
Ability to interact effectively at all organizational levels
Flexibility, adaptability, and multi-tasking
