Process Engineer I/ II/ Lead Engineer I
Date Posted
7/24/23
Location
Dayton, OH
Position Id
2082
Degree Required
Job Type
Job Description
Job Description:
This position will provide support and assistance in the manufacture of pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to production facility, design and recommend equipment purchases, write and execute equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes.
Requirements:
- Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
- Thorough knowledge of automated control systems.
- Thorough knowledge of computer systems operation and software.
- Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
- Knowledge of chemistry, statistics, equipment design, process control and process scale-up.
- Knowledge of oral solid dose pharmaceutical operations preferred and equipment validations.
- "Hands-on" ability to install and troubleshoot instrumentation and equipment.
- Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
- Ability to author high quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications, SOPs, deviation investigations).
- Ability to specify and size manufacturing systems, equipment, and process equipment.
- Ability to gown for clean room operations.
- Ability to read, understand and accurately follow company SOPs and guidelines.
Personal Attributes Needed:
- Excellent communication and documentation skills.
- Excellent organizational skills.
- Ability to self-manage and prioritize workload.
- Ability to react quickly to understand and solve problems.
- Excellent troubleshooting skills.
- Positive attitude.
Process Engineer I - Basic Qualifications:
- BS degree in Engineering or technical discipline.
- 0-2 year of manufacturing experience or technical experience.
Preferred Qualification:
- 0-2 years of pharmaceutical experience.
- Experienced working on (and coordination of) multiple projects in an orderly and efficient manner; while consistently meeting established deadlines.
- Experienced in working successfully across functions to meet company objectives.
Process Engineer II - Basic Qualifications:
- BS degree in Engineering or technical discipline.
- 2-5 year of manufacturing experience or technical experience.
Preferred Qualification:
- 2-5 years of pharmaceutical experience.
- Experienced working on (and coordination of) multiple projects in an orderly and efficient manner; while consistently meeting established deadlines.
- Experienced in working successfully across functions to meet company objectives.
Lead Engineer I - Basic Qualifications:
- BS degree in Engineering or technical discipline.
- 5+ year of manufacturing experience or technical experience.
Preferred Qualification:
- 5+ years of pharmaceutical experience.
- Experienced working on (and coordination of) multiple projects in an orderly and efficient manner; while consistently meeting established deadlines.
- Experienced in working successfully across functions to meet company objectives.