Process Engineer I/ II/ Lead Engineer I

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.