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The position will provide process engineering technical support to operations. In this role, the individual will plan, design, implement, and manage continuous improvement systems to enhance business objectives and operational performance. This may include developing processes and procedures for manufacturing and packaging, performing validation evaluations, and writing/executing validation protocols. Additional responsibilities include developing and managing data collection systems for continuous feedback to production and maintenance, as well as assisting with the preparation and execution of capital and expense projects.

This role supports the implementation and execution of key food safety design analytical methods within the US by managing media preparation- quality control activities- and executing project work to develop microbiological and analytical methods needed to support food safety design and commercialization. The position provides onsite laboratory support and project execution support to Corporate Quality & Food Safety and R&D.

Primary Responsibilities:

• Lead, design, install, commission, and start-up as well as maintain and improve the liquid, and aseptic process and equipment.
• Responsible for the process engineering and improvements in material handling, ingredients preparation, receiving, CIP, liquid process, and aseptic process.
• Ensures compliance of process parameters and operational conditions with Applicable FDA Title 21, Code of Federal Regulations (CFR) such as 21 CFR parts 105, 106, 107, 108, 110, 113, 117, 120, 121, & FD&C Act Chapter IV: Food: Sec. 412 Title 350a - Infant formulas.
• Responsible for improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence.
• As subject matter expert, provide technical leadership in CIP, liquid process, and aseptic operations.
• Authors and reviews documents, including Preventive Maintenance plans, Standard Operating Procedures, Batch Records, Material specifications, and other forms.
• Author and review validation and change control documents such as master plans, validation protocols, summary reports, and change requests
• Develop project justification and engineering proposals for capital credit submission.
• Proficient problem-solving methodologies (DMAIC, GSTD, or BDA)
• Proficient in data analysis and loss deployment.
• Proficient skills in troubleshooting mechanical, process, and automation-related issues.

Planning and Organizing:

• Utilizes FEL process to analyze available data, plan, design, and implement the best value options that result in low cost/high efficiency and renovation/innovation improvements (including the development and organization of necessary systems).
• May own one or more Focused Improvement systems.

Communication:

• Coordinates with the Business Unit, Engineering, Maintenance, and others as necessary to provide information regarding necessary improvements to equipment/processes to reach targets.
• Participates in budget preparation and capital expenditure recommendations.
• Tracks and reports progress on departmental DMAICs, GSTD and BDA.
• Utilizes the Management of Change process as needed.

Training:

• Acts as Subject Matter Expert to provide assistance as necessary to the Supervisors and Training Coordinators in order for the coordinators to provide appropriate training to employees entering the department or as needed for process changes.
• Support project completion through media preparation- quality control activities- and through execution of microbial testing on a project-by-project basis
• Support design and execute challenge studies- shelf-life studies and validation studies to determine critical limits for critical processes. Partner with external institutions and business partners to update/maintain CCP models.
• Supports the execution of validation studies- to evaluate and approve microbiological test methods (rapid and cultural) for the LactaLogics laboratory network.
• Supports proficiency testing program and internal laboratory audit process for internal factories laboratories.
• This role provides scientific and technical food safety support to US business partners to ensure product safety and quality by participating in the evaluation of analytical methods. Identify and communicate method-related impacts on factory verification programs.
• Support validation of designed HACCP preventive controls (processing- formulation- etc.) and assess the validity of data obtained by others.
• Remain current in scientific and regulatory food safety principles to ensure most relevant information and emerging issues are identified and incorporated into LactaLogics safety programs.
• Supports administrative tasks such as managing inventory- ordering supplies- and data entry.
• Supports cross-functional communication of results with internally and externally generated data.

Resolving Problems:

• Proficient in problem-solving methodologies (DMAIC, GSTD, or BDA)
• Proficient in data analysis and loss deployment
• Proficient skills in troubleshooting mechanical, process, and automation-related issues

Bachelor’s Degree in Mechanical, Chemical, or Food Engineering or equivalent with experience in the infant formula, food, beverage, dairy, or CPG industries, preferred