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Senior Engineer - Process Engineering - Bloomington Indiana
Company: Disability Solutions Location: Bloomington, Indiana
Posted On: 05/12/2024
Senior Engineer - Process EngineeringCatalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Process Engineering focuses on developing processes to minimize risks to the product. The role works with industry experts/consultants to create design specifications, P&ID drawings, general arrangement drawings, user requirements, functional specifications, and automation control strategies. Provides technical solutions to complex problems by relying upon their experience and/or seeking recommendations from industry experts.The Engineer will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight.This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements. The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs.This person will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.This is a full-time, salary position. The shift is Monday- Friday, days Catalent Pharma Solutions in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better healthier lives.Catalent is committed to a Patient First culture through excellence in quality and compliance and to the safety of every patient, consumer, and Catalent employee.The Role: - Support the multi-use facility, including HVAC systems and bio-containment systems
- Support selection and installation of manufacturing equipment
- Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements
- Draft SOPs for building operation, maintenance, and calibration
- Identify improvements and efficiencies of facility preventative maintenance
- Provide engineering guidance and execution on facilities and equipment projects
- Perform hands-on activities as needed to help troubleshoot facility problems and support facility staff
- Develop standard processes to evaluate future capital projects
- Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety
- Create and maintain all aspects of equipment design files
- Guide the specification and selection of manufacturing/utility equipment to support site facility/process needs
- Monitor, maintain, and repair existing production and laboratory control and monitoring systems (PLC, sub-networks, software, etc.)
- Apply and enhance existing automation validation programs for the validation of new and existing production and laboratory automated systems, including major capital projects and continuous improvement of systems
- Review and approve changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems
- Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation system validation
- Identify and implement improvement opportunities for established production systemsThe Candidate:
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline, required
- Master's degree, preferred
- PE / Registered Engineer in training, preferred
- OSHA/IOSH/NeBOSH Certification or equivalent, preferred
- 5+ years Project Engineering relevant experience
- 2+ years in a regulated industry (Life Sciences, preferred)
- Must be able to read and understand English-written job instructions and safety requirementsWhy you should join Catalent:
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