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Process Engineer
2 months ago
Functions:
- Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed.
- Proactively identify engineering problems or opportunities and apply technical expertise to develop and present feasible solutions.
- Lead and manage new equipment/systems installation including infrastructure, connectivity and capacity assessments.
- Lead and manage process improvements, corrective and preventive actions (CAPAs) and change controls implementation for process equipment and site utilities.
- Lead the identification of new equipment including but not limited to proper type, size, materials of construction, throughput, operational conditions, physical dimensions, required utilities, waste requirements, user requirements specifications (URS) and others.
- Support new product introductions (NPIs).
- Work with process sciences in developing new equipment/systems/process design, controls, requirements, specifications and drawings.
- Liaison with CAPEX team for the implementation of capital projects.
- Coordinate execution of projects, improvements and other engineering activities.
- Oversee contractors when implementation and/or corrections are required.
- Works with QA/QC to ensure proper testing, inspection and release after completion of engineering activities.
- Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
- Ensure new equipment operates in compliance with required EHS, regulations and codes.
- Develop, write, edit and/or review in collaboration with Facilities SOPs, P&IDs and maintenance procedures for new equipment and/or systems.
- Communicate efficiently with Contractors, Suppliers, OEM providers as well as internal equipment owners and operators for a successful operation of the FDBT facility.
- Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility, and document out of specification conditions with deviations, CAPAs and Change Controls as appropriate.
- Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, site procedures and job performance qualifications.
- All other duties as assigned.
- Able to identify potential problem areas of equipment that is malfunctioning, using technical manuals or mechanical, electrical or controls knowledge.
- Demonstrate leadership, technical aptitude, and problem-solving skills.
- Knowledge and understanding using P&IDs, equipment manuals, specifications, SOPs, and be able to use proper judgment when implementing projects or taking corrective actions during equipment malfunctioning.
- Must be able to develop, and draft operational procedures and maintenance procedures for technical (utilities/process) equipment using the OEM manual and system knowledge.
- Possess or have the ability to gain knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements.
- Must be able to use project management software such as Microsoft Project.
- Strong written and verbal communications skills.
- Knowledge of bio-medical, bio-technical equipment, both upstream and downstream highly desirable.
- All other duties as assigned.
Qualifications:
- Bachelor's Degree preferably in Electrical, Chemical, Mechanical or Biomedical Engineering
- Six (6) years of qualified experience in an engineering role in an FDA regulated research or manufacturing facility
- Knowledge of bio-processing equipment, clean utilities, and single use equipment
- Knowledge of quality management software specifically Trackwise
