US - Process Engineer

Responsibilities

• Resolve technical issues with the equipment as it pertains to the process requirements.
• Optimize and improve the process equipment.
• Identify root cause for deviations, define corrective and preventative actions and implement new or replacement equipment as required.
• Support or lead system change requests associated with the validated equipment or systems.
• Prepare required documentation/packages for process equipment and cleaning systems in preparation for regulatory inspections or audits.
• Provide equipment engineering support of pharmaceutical manufacturing equipment for new facility.
• Develop preventative and predictive maintenance plans for process systems to attain the highest reliability.
• Responsible for reliability and readiness of process equipment and systems to ensure operational efficiency.
• Assist in developing procedures for operating and maintenance for process equipment.
• Support or lead FAT, SAT, commissioning and qualification activities for new or modified systems.
• Offer critical assistance of harvest equipment includes tanks, centrifuges and harvest filtration skids, cleaning equipment and other support systems such as CIP and COP.
• Perform all work in accordance with all established regulatory, compliance, safety requirements and good engineering practice.

Qualifications

• Process engineering with demonstrated CAPEX experience in the pharmaceutical industry.
• Must have experience in upstream/downstream bioprocesses and equipment.
• Working knowledge of PFD, P&I Diagrams, Mass Balance and be able to perform engineering calculations.
• Should be proficient in technical writing.
• Bachelor Degree in Chemical Engineering or equivalent discipline.
• High level of familiarity with Excel, Word, Access required.