Senior Equipment Engineer

Purpose and Scope

Design and implement production equipment and associated automation, controls, and processes to be used in the manufacturing and packaging of novel delivery system formulations and controlled release products as well as other aseptic products. The Senior Equipment Engineer is responsible for leading cross functional efforts to establish and maintain strategies, processes, metrics, and engineering standards for improving equipment, systems, and processes to achieve cost effectiveness, improve product quality and on-time performance. The position will also support the Research & Development teams in identification and development of process related equipment and automated control systems to be used in the production of registration batches through scale-up and final commercial shipments to Tolmar's customers. A person in the senior role is not a direct supervisor, but may take on a leadership role to guide decision making and coordinate efforts of other team members toward engineering and technical operation's goals.

Essential Duties & Responsibilities

• Select, purchase, qualify and support technical trouble shooting of equipment for processing, controlling, packaging, and transporting raw ingredients, formulations, intermediates, work in process, and/or finished products. Develop engineering solutions using the integration of several types of commercial controllers which include PLCs, PACs, etc.
• Write protocols, reports, batch records, procedures and other controlled and necessary GMP documentation. Perform or assist IQ/OQ and PQ validations of equipment and systems.
• Actively pursue collaborative cooperation with other departments (Quality, Maintenance, IT, Project Management, etc.) in troubleshooting and optimizing equipment and related processes, by performing root cause analysis, engineering studies, DOE studies, implementing appropriate metrics to improve existing equipment and processes.
• Provide senior level mentoring to team members and cross functional project teams to promote excellence. Independently manage complex equipment installations/qualifications, or improvement projects.
• Create and manage complex project plans for successful execution of project milestones. Effectively manage and direct third party suppliers and contractors, along with associated capital budgets and expenses.
• Take ownership of developing process/product knowledge by applying quality by design principles and effective engineering practices and standards throughout the project lifecycle.
• Serve as the subject matter expert for serialization hardware and software, including integration to existing manufacturing equipment.
• Serve as the subject matter expert for vision systems, including integration into existing manufacturing equipment.
• Provide serialization training to maintenance and manufacturing operations technicians.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Technical expert in one or more process engineering areas.
• Understanding of PLC logic, Equipment Integration, and Automation concepts.
• Expert knowledge of serialization systems from Levels 1 through 4.
• Understanding of vision systems including Optel, SeaVision, Cognex, and Keyence.
• Expert knowledge of FDA guidelines and cGMP Procedures and knowledge of current trends.
• Excellent professional written and verbal communication and interpersonal skills.
• Ability to independently manage multiple projects with minimal supervision.
• High attention to detail and sense of personal responsibility.
• Senior level technical abilities to analyze complex problems, using sound Engineering practices and tools, resulting in effective and creative solutions.

Education & Experience

• Bachelor's Degree in Engineering required.
• Eight or more years' experience in engineering related role in the pharmaceutical or medical device industry.
• Four or more years working with serialization systems.
• Engineering experience with all aspects of pharmaceutical equipment (processing, cleaning, packaging, automation and controls, sterile and non-sterile preferred) installation, qualification, and on-going commercial support and improvements.

Working Conditions

Working conditions are in an office, laboratory and manufacturing environment. Work may require occasional weekend and/or evening work.