Plant Engineer

FLSA Status – Exempt

Position Summary
Provides technical leadership across business units to enhance the efficiency, quality, compliance, customer service, and safety of Austin pharmaceutical manufacturing operations. Evaluate existing calibration processes, calibration standards and equipment against current industry and compendial standards and best practices. Suggest and evaluate improvement alternatives and assists with implementation of process improvements. Work closely with maintenance and engineering. Provides project management to secure funding, plan and execute projects. Leads complex aspects of multiple projects. Provide technical support to Validation. Serves as subject matter expert and administrator of the Calibration Management System.

Essential Duties & Responsibilities

• Administrator of the Calibration Management System.
• Analyzes, plans, organizes, and completes technical projects of a complex nature. Develops scope and provides creative solutions.
• Provides technical expertise (SME) for calibration processes. Participate in and lead troubleshooting of issues arising in existing processes. Uses creative approaches in solving complex problems.
• Identify and evaluate opportunities for process improvement.
• Develop long range replacement and shorter-range continuous improvement project plans.
• Leads and implements projects; manages schedule and progress updates; presents project status to site leadership.
• Works on problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
• Largely self-directed after work is assigned; solicits input from senior level engineers.
• Trains new employees on use of equipment, system and equipment documentation, and department procedures. Provides input on performance evaluations to area manager.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
• Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.
• Work on special projects as they arise.

Knowledge, Skills & Qualifications

• Has mastered best practices. Has an advanced and broad understanding of various measurement disciplines. Knowledgeable in flow, pressure, temperature, conductivity and mass calibrations. Knowledge of chemical analytical instruments is desirable.
• Expert in calibration and familiar with the requirements of ISO-17025. Familiar in other areas of domain expertise within the team.

Education and Experience

• Must be at least 18 years of age.
• Bachelor’s Degree is required, any engineering or science field. Preferred disciplines are: Electrical, Mechanical, Chemical, Biomedical engineering, Mathematics, Statistics, Chemistry or Physics.
• Minimum of 7 years of experience required. Preferred experience: calibration in a manufacturing, utilities or laboratory environment engineering or maintenance and / or experience as Process Engineer implementing improvements in a manufacturing environment.
• Work experience in pharmaceuticals or a regulated environment is desirable.

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Some work is performed in a clean room environment.
• Must be able to occasionally move and lift objects of up to 25 kgs.
• Typically requires travel less than 5% of the time.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.