What you will do
The Capital Equipment Engineer, is responsible for technical support, including specification, development, implementation, and assurance of a qualified state for packaging equipment. Aligns 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
- 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 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.
- Plan and execute equipment strategies by providing engineering solutions, technical advice, and assistance to Packaging and other departments as required.
- 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.
- 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.
- Lead, develop, write, and gain cross functional alignment of required documentation for equipment systems qualifications and/or validations.
- 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 as needed by improving compliance, quality, efficiency, and cost.
- Support and/or lead the development and assessment of the following types of information to support life cycle management initiatives, including but not limited to: design requirements, definition of the scope of change, packaging equipment solution proposals, prior knowledge and knowledge gap assessments, risk assessments, test plans, and test results analysis and conclusions
- Develop, write, get cross-functional alignment, and route for approval qualification documentation (Examples: User Requirement Specifications, System Test Matrix, Intallation and Operational Qualification, reports, Project Qualification Plan, etc.)
- 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.
- 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.
- Performs other related duties as required.
What we are looking for
Required Qualifications
- Bachelor of Science degree (or equivalent) in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or Industrial Engineering.
- 4 + years of pharmaceutical manufacturing related experience is required and excellent verbal, writing and technical writing skills in both languages
- Experience in Equipment qualification and Computer System Validation
- Knowledge of GMPs, ICH, CFR is required
- Knowledge of installation and troubleshooting of solid oral dose production and packaging equipment.
- Basic computer knowledge (Microsoft Office software - Excel, PowerPoint, Word).
Desired Qualification
- Advanced degree preferred
