Process Engineer Jobs

About The Position

Requirements

• Minimum of a Bachelor’s or equivalent experience in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field.
• Minimum 4 years of relevant work experience.
• Experience in one of more of the following areas: cGMP manufacturing, operations technology development, tech transfer, process and equipment validation, and/or quality management.
• Ability to collaborate internally and externally within a matrix environment.
• A start-up/can-do attitude and proactively search for solutions.
• Thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution.
• Work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.
• You are able to concisely summarize and present results.

Nice To Haves

• Experience working in a plant manufacturing environment.
• Experience with equipment/systems commissioning/qualification/validation.
• Deploying new technology into operations, IT/Automation systems, cell therapy (CAR-T) is an asset.

Responsibilities

• Provide operational expertise based upon a combination of GMP knowledge of facility design, knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable to cell and gene therapy products.
• Provide operational expertise in GMP support processes, for instance, cleaning, environmental monitoring, gowning, waste, GMP documentation needs, etc.
• Translates input into operational performance efficiencies for user requirements for new technology and processes.
• Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.
• Provide operational input to the facility resource model. Leverage the model to shape the development and operability of GMP support processes to deliver solutions for cost competitiveness.
• Support development and implementation of change control strategy, risk assessment strategy, and qualification strategy to ensure operability and scale out considerations within the quality and regulatory requirements.
• Immerse yourself in CAR-T processes, build up solid expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records etc., and ensure adequate training of the organization.
• Ensure end-to-end overview of the flow of all material required in your area, including process material, documents, waste, samples.
• Identify risks and opportunities in relation to process, contamination, cross contamination and mix-up control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QA, QC and operations management.
• Act as a lead in root cause related to safety/quality issues in your area.
• Act as a spokesperson for your area during health care inspections.
• Support the lean design and implementation of Information Technology systems (SAP, MES, etc) including future releases to continuously improve performance and compliance.
• Develop an appropriate governance structure to monitor the operational performance of your area at acceptance testing, startup and ongoing.
• Develop & maintain in depth understanding of the mfg. processes (incl. sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes
• Develop & maintain robust understanding of aseptic and cell processing techniques.
• Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP) an understanding of biosafety

Benefits

• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours