Process Engineer II

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Job description details provided below. The Process Engineer II supports technology transfer of client processes and executes engineering functions including design, scale-up, and documentation. This role functions as a program lead with direction from functional group leadership and provides guidance and training to supporting team members.

Process Engineer II in Albuquerque, NM. Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. We are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

The Process Engineer II is responsible for facilitating the technology transfer of client processes and executing engineering functions including design, scale-up, and documentation. This role functions as a program lead with direction from the functional group leadership. The engineer provides guidance and instruction to supporting team members on tasks related to their project and training for new team members.

• Develops batch records and leads process activities for client-specific formulation and filling operations for at least one client; oversees critical operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support
• Acts as an SME for GMP investigations (CAPA, departures, CCRs) from initiation to closure
• Finalizes closure reports for the departures assigned to process engineering
• Direct client interaction for routine discussions, summarizing engineering-related work completed verbally and in writing; client communication will be supported by more senior engineers, as needed
• Identify and specify process-specific equipment based on facility, client, and program needs; author instructions for operation of equipment and detailing process flows in the cleanroom facility
• Develop new procedures to meet facility and client requirements
• Adhere to safety requirements at all times
• Design and provide training on operation tasks, such as those captured in SOPs or work instructions
• Provide training on client programs and processes
• Communicate deviations to appropriate leaders involved in the production process
• Read/interpret SOPs to ensure compliance
• Maintain up-to-date trainings
• Other duties as assigned

• Bachelor’s degree in Biology, Chemical Engineering, or related field of study
• Minimum of three (3) years’ experience in pharmaceutical, biotech, or related industry
• Minimum of three (3) years’ experience in process engineering
• Experience with aseptic fill/finish is preferred

This role does not have supervisory responsibilities, but may involve mentoring, guiding, and advising.

• Language
  
  Skills:
  
  ability to read and interpret documents such as safety instructions, standard operating procedures, technical procedures, and regulations; strong written and verbal communication and presentation skills
• Mathematical
  
  Skills:
  
  proficient in arithmetic, algebra, and geometry across units of measurement
• Reasoning Ability: able to define problems, collect data, establish facts, and draw valid conclusions
• Computer
  
  Skills:
  
  strong foundation in software tools; proficiency with Microsoft Office Suite; manufacturing and internet software
• Other
  
  Skills:
  
  provides guidance and mentorship, fosters collaboration, promotes safety, attention to detail, ability to work with moderate supervision, strong communication, and a structured, organized approach; familiarity with aseptic technique and cleanroom personnel flows is desirable
• Knowledge of process flows, disposable strategies, filtration, mixing, and fluid transfer is a plus
• Working knowledge of sanitary connections, valves, and pharmaceutical process design

• Must pass a background check
• Must pass a drug screen
• Must obtain and maintain gowning certification
• May be required to obtain and maintain…