Published: April 4, 2018
- Provide technical leadership for the specification, development, implementation, and assurance of a qualified state for manufacturing equipment in the respective site.
- You will align manufacturing equipment requirements with the site’s mission, ensuring efficient and effective equipment operation meeting cost, customer service, and quality/compliance goals.
- Lead the site’s capital plan, manufacturing equipment asset management, and automation strategy.
- Manage capital appropriation approval and spending management.
- Manage a group, including equipment and automation engineers, to deliver key projects driving business results in alignment with regulatory standards, site goals and objectives.
- Ensure compliance with technical and regulatory standards including but not limited to Commissioning and Qualification, Computer System Validation, Systems Integration, and internal requirements such as Change Control and Periodic Review of Qualified Systems.
- Own the manufacturing equipment across the equipment life cycle, including reliability and ME2 strategy.
- Ensure quality and compliance in all actions by: attending Good Manufacturing Practices (GMP) training, adhering to strict compliance with procedures applicable to role, exercising the highest level of integrity in the tasks performed, identifying, reporting and seeking correction for deviations noted in the workplace, and embracing a behavior of employee involvement and commitment to doing the job right the first time.
- Assign, guide, and direct engineering projects and works in support of business priorities, and ensure the delivery of compliant, efficient, and cost-effective engineering solutions on-time and on-budget.
- Lead staff in the development of engineering solutions through good Engineering practices and process excellence tools to deliver innovation and improve business results, and prepare, coordinate, and monitor capital projects from initiation of Capital Appropriation Request (CAR) through Project and Change Control closure.
- Collaborates with internal (Project Management, Quality, Manufacturing, Technical Operations Process and Validation) and external partners/groups in support of new product launches, process and equipment improvements, automation, and other projects driving cost reduction, supply reliability, and quality compliance improvement.
- Provide technical support for manufacturing troubleshooting, Non-Conformance (NC) investigations, and Corrective/Preventive Actions (CAPAs), and leads the development and implementation of Equipment Engineering strategies and projects in collaboration and alignment with the operational strategies and those of the Enterprise Supply Chain.
- A bachelor’s or higher degree in Engineering is required, preferably with a focus in Mechanical, Electrical, Industrial or Computer Engineering. Masters of Business Administration (MBA) or Masters in Engineering/Engineering Management is a plus.
Professional Engineer (PE) license, Six Sigma, Lean, Reliability/Maintenance, or structured problem-solving (e.g. Kepner-Tregoe) certifications are preferred.
- At least eight (8) years of overall experience in one or more of the following areas is required: equipment engineering, equipment design, process/equipment automation, systems integration, equipment commissioning or qualification including CSV.
- Experience in the Over-the-Counter (OTC) or Pharmaceutical industry is required. Prior experience with solid dose manufacturing is highly preferred.
- A minimum of three (3) years of people management or team leadership experience is required.
- Thorough knowledge and application of equipment and system qualification standards and life-cycle management from User requirement specification (URS) through qualification and change control is required.
- Ability to provide technical leadership in complex problem-solving and decision-making, to collaborate with and influence business partner leaders with a focus on data, science, and technology is required. As well as the ability to constructively challenge direct reports and project teams to achieve project goals and implement innovative solutions is required.
- Strong understanding and application of cost analysis and budget management is required.
- Demonstrated project management skills associated with capital projects is required.
- Strong written and oral communication skills both in English and Spanish is required.
- Proficiency in the use of Microsoft Office tools (Word, Excel, PowerPoint, Outlook) is required. Experience with Manufacturing Execution System (MES), MS Project, SCADA, Wonderware or OSIPI is preferred.
- This position requires up to twenty-five percent (25%) travel.