Senior Engineer

The Senior Engineer is responsible for technical support, including specification, development, implementation and assurance of a qualified state for manufacturing equipment. 

Aligns manufacturing and/or packaging equipment requirements with the site’s needs, ensuring customer service, and quality/compliance goals. 

Responsible for project’s capital plan and equipment asset management, and reliability. Manages capital appropriation approval for assigned projects and spending management. Leads cross functional teams that includes equipment, automation, and packaging engineers to deliver key projects driving business results in alignment with the site goals and objectives.

Key Responsibilities

• Plan and execute multiple and/or major equipment and validation projects concerned with life cycle management initiatives and develop risk mitigation strategies to deliver project commitments.
• Understand and improve assigned processes and various equipment technologies across multiple locations simultaneously. This person will work with and benchmark with sites to provide the best-in-class processes to the company.
• Plan and execute equipment and validations strategies aligned to the consumer asset management strategies to assigned areas within the company. Responsibilities include understanding existing limitations and developing technical solutions to eliminate waste.
• Lead equipment installation, qualification, validation and start up for assigned projects, and communicate potential issues and give clear direction to site teams to ensure successful project execution.
• Plan and execute equipment strategies by providing engineering solutions, technical advice, and assistance to Manufacturing and other departments as required.
• Develop and execute plans related to equipment that maintain high levels of Operational Equipment Efficiency (OEE) to assigned areas. Drives value through identifying and executing multi-site projects by improving compliance, quality, efficiency, and cost.
• Lead, develop, write, and gain cross functional alignment of required documentation for equipment systems qualifications and/or validations.
• Support and /or lead the execution of line trials, engineering studies, equipment qualification and process performance qualification.
• Ensure all trainings and if applicable, those of direct reports, are current and successfully completed prior to the execution of specific work activities.
• Support and/or lead the development, execution and/or review of change controls for equipment and validation related changes.
• Provide technical support and/or lead equipment/process troubleshooting related to equipment troubleshooting and improvements, use applicable tools (e.g., Kepner Tregoe, DMAIC, etc.) to facilitate root cause identification, write and/or approve reports as required (technical memos, Non-Conformance (NC), and Corrective/Preventive Actions (CAPAs).
• Provide input to the Long-Range Financial Plan for the assigned area.
• Prepares or approves Equipment Periodic Review.
• Writes or approves SOPs based on area of experience and training. Provides technical advice on SOP’s, policies, and procedures.
• Manage investigations, CAPAs, and APR data collection, analysis, and review/approval.
• Reviews and approves Commissioning and Qualification documentation such as plans, protocols, and reports as required.
• Reviews and approves Computers System Validation documentation such as plans, User Requirements (URS), Functional Design Specification (FDS), Traceability Matrix (TRM) protocols and reports as required.
• Reviews and approves Package Validation documentation such as protocols and reports as required.
• May provide direction and mentorship to Co-ops and entry level engineers.
• Maintains training proficiency on cGMPS, SOP’s, testing procedures, and data analysis as required.
• Conducts interdependent partnering with cross-functional peer group and management.
• Works under minimal supervision.
• Decisions made at this level may have direct impact on supply chain.
• Leads a technical team or primary technical lead on cross functional teams. Ability to lead and coordinate project activities, resources, etc.
• Effectively influence people, multiple projects, and tasks of various complexities.
• Solves difficult and complex technical issues that have substantial impact on the product quality and business outcomes.
• Accountable for assigned project capital plan, monthly and quarterly expenditures and cashflow forecast, contingencies, and scope management.
• Manage projects using Project Management tools as project timeline, kickoff meetings, risk and mitigation logs, issue and action logs, decisions log, change logs and stabilization plan between others as applicable.
• Serve as an area owner and provide inputs for the long-range financial plan (LRFP) and the integration with the 5-year asset replacement plan. Help to manage area strategies and roadmap including but not limiting reliability and automation strategies integration.
• Performs other related duties as required.