Senior Process Engineer

Must Haves:

• Bachelor's Degree in Engineering or related field
• 7 years of in facilities process engineering
• Progressively responsible facilities development, facilities construction, and maintenance activities
• Understanding of cGMP requirements
• Diverse understanding the electrical, mechanical, architectural design and construction disciplines

Pluses:

• Master's Degree in Engineering or related field
• Pharmaceutical or biotechnology experience

Job Description:

A pharmaceutical manufacturing client is seeking a Facilities Process Engineer III in the Durham, NC area.

Responsibilities:

• Direct concurrent engineering projects both technical and project management aspects for capital projects while ensuring their success in meeting their respective objectives.
• Technical aspects include Architectural features, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, Automation.
• Collaborate with MS&T and manufacturing teams to design and optimize bioreactor systems and cell culture processes.
• Develop and implement engineering/ test protocols for media preparation, inoculation, fermentation, and scale-up production.
• Troubleshoot and resolve equipment and process-related issues in bioreactor systems.
• Monitor and analyze process data to improve yield, quality, and consistency of upstream processes.
• Oversee equipment operations involving centrifugation, chromatography, filtration, and other purification processes.
• Collaborate with MS&T to optimize downstream processes to ensure high product recovery and purity.
• Support Validations with the development and execution protocols for cleaning and validation of downstream equipment.
• Support the integration of new downstream technologies into existing manufacturing processes.
• Ensure the proper installation, qualification, and maintenance of upstream and downstream process equipment.
• Develop and maintain SOPs (Standard Operating Procedures) and process documentation.
• Partner with equipment vendors and contractors to troubleshoot and resolve technical issues.
• Lead investigations and corrective actions for equipment deviations and failures.
• Project Management aspects include scope definition, scope adherence, stakeholder concurrence, budgeting, scheduling, risk management, procurement and installation support, including coordinating the activities of contract engineers and trade contractors during system modifications/additions.
• Support the Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities and equipment.as well as ensuring the facilities comply with all local, state, federal, and corporate guidelines related to health safety and environmental functions
• Support Validation with the planning and execution of commissioning and validation protocols.
• Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis and other Quality Systems.
• Develop and maintain standard operating procedures and other procedures for installed systems.
• Support and comply with engineering standards, drawing controls, project controls and other procedures and standards necessary for the successful operation of the department as well as the creation and maintenance of the same.
• Other assigned duties.