Role Impact: As part of a startup, early-stage company, the Senior Process Engineer will be critical in providing process engineering technical support to operations; creating an opportunity for this position to highly impact and influence the future of the organization.
In this role, the Senior Process Engineer will plan, design, implement and manage 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 assist with the preparation and execution of capital and expense projects.
Role Responsibilities:- Lead, design, install, commission, as well as maintain and improve low acid aseptic process and equipment.
- Implements and maintains plant equipment, systems and other fixed assets to a high standard of safety, quality, and productivity.
- Provides process and engineering support to all aspect of the operation.
- Responsible for the process engineering and improvements in dairy receiving, batching/blending, pasteurization, UHT Processing, and aseptic filling.
- Works to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent reoccurrence.
- Ensures compliance of process parameters and operational conditions with USDA and FDA regulations.
- Responsible for improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence.
- Strong collaboration with other key functions on executing projects.
- As a subject matter expert, provide technical leadership in the areas of CIP.
- 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.
- Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
- Collaborate with production as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.
- Perform on-site troubleshooting during process scale-up and introduction.
- Supporting process investigations and product impact assessments for change controls and internal/external investigations.
- Create equipment/process specifications, drawings, and software as required and ensure that existing documentation is accurate and appropriate.
- Develop project justification and engineering proposals for capital credit submission.
- Acts as Subject Matter Expert by providing appropriate training to employees entering the department or as needed for process changes. Monitor production to determine areas of improvement and react to unforeseen production/manufacturing issues.
- Oversee the operation and maintenance of the RO water system to ensure optimal performance and compliance with industry standards.
- Follow Food Safety Requirement/Standards as needed.
Supervisory Responsibilities- Mentor, and train new process engineers
Education- Bachelor's degree in Process, Chemical or Mechanical Engineering required.
- MBA preferred
Experience & Skills- 5 to 7 years of engineering experience in aseptic processing or equivalent in GMP, FDA, ISO, OSHA, USDA or PMO regulated environment.
- Low Acid Aseptic and ESL manufacturing and packaging experience preferred.
- Dairy Manufacturing experience preferred.
- Proficient on problem solving methodologies; root cause analysis, fishbone, 8D.
- Proficient on data analysis and loss deployment.
- Proficient skills in troubleshooting mechanical, process, and automation related issues
- Strong teamwork skills and ability to direct others
- Understanding of various software (Allen Bradley, Siemens, B&R), HMI's, and equipment alarms
- Extensive knowledge of engineering principles and procedures.
- Excellent analytical and management skills.
- Excellent verbal and written communication skills.
- Excellent organizational skills and attention to detail.
- Excellent interpersonal skills.
- Proficient with Microsoft Office Suite or related software.
Physical Requirements: - Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to15 pounds at times.
- Must be able to work with equipment that contains electric magnetic components.
