Quick overview
Job description
Position Summary
Provides technical leadership for the assigned business unit to enhance the efficiency, quality, compliance, customer service, and safety of Austin pharmaceutical manufacturing operations. Evaluate existing processes and equipment, suggest and evaluate improvement alternatives, and assists with implementation of process improvements. Work closely with maintenance. Provide technical support to project management to secure funding, help plan and execute large projects. Provides project management to secure funding, plan and executes moderately complex projects. Provide technical support to Validation.
Essential Duties & Responsibilities
- Provides technical expertise (SME) for assigned processes. Participate in and lead troubleshooting of issues arising in existing processes.
- Provide the technical expertise and continuity thought process to effectively analyze inefficient machine/equipment operation and affect cost effective remedies. Uses creative approaches in solving complex problems.
- Identify and evaluate opportunities for process improvement.
- Provide technical input to help develop long range replacement and shorter-range continuous improvement project plans.
- Provide project scope, design, FAT, SAT, start-up, commissioning, and supports validation for new equipment. Works on and leads aspects of larger project teams.
- Develops and writes detailed design specifications. Provides technical input for project scope development and execution.
- 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. May provide 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 in-depth understanding of best practices. Has an intermediate understanding of engineering discipline.
- Have a solid understanding of the equipment strategy and can recommend solutions to critical issues.
- Requires the ability to make significant decisions directly impacting the success of one or more projects, or adjacent workgroups/functions.
- Advanced in your domain. Familiar in other areas of domain expertise within the team.
Education and Experience
- Bachelor’s Degree is required, any engineering field. Preferred disciplines are: Mechanical, Chemical or Biomedical engineering.
- Minimum of 4 years of experience required. Preferred experience: manufacturing, utilities 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.
Minimum Qualifications
- Must be at least 18 years of age.
Travel Requirements
- Typically requires travel less than 5% of the time.
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 lbs.
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