The Shift Process Engineer performs all manufacturing tasks required for the safe production of active pharmaceutical ingredients in compliance with FDA, DEA, OSHA, Federal, State, and Local regulations. The primary objective of this position is to ensure that all manufacturing operations are conducted in a safe manner with a high regard for all applicable cGMP's and DEA requirements. Working flexibility across a broad range of chemical operations and participation on self-managed work teams is required. Training for and participation on Emergency Response Team is required. Availability for overtime and shift work (including rotating shifts and seven-day operation) is also required.
Educational Requirements BS Degree in Chemical Engineering or Chemistry.
- Provide technical assistance chemical technicians in order in troubleshoot and problem solve both process and equipment related problems. - Achieve cycle time requirements in order to meet the production schedule. - Attend Process Hazard Analyses (PHAs') for manufacturing operations. - Prepare and revise production batch records and standard operating procedures (SOP's) - Provide training to chemical technicians on production batch records and SOP's - Work as a team member with the chemical technicians. Perform chemical operations as required. - Perform the role of DEA coordinator. This requires witnessing all movement of controlled materials. Attend all required cGMP, DEA and ESHA training. - Perform in process analytical testing and performing bench scale chemistry in the laboratory, when applicable. Seek out and identify opportunities for systems and process improvements.
Required Experience & Technical Requirements 1 - 2 years of related work experience in manufacturing or engineering in a chemical or pharmaceutical environment is preferred.
Ms. Deborah Miller Shell Recruiter
Purdue Pharma - 23 months ago
Purdue Pharma helps bring patients relief from pain. The company specializes in developing, manufacturing, and marketing prescription and...