Senior Principal Process Engineer - ABQ

Company: Curia
Location: Amityville
Posted on: March 20, 2023

Job Description:

Summary:

The Process Engineer will be responsible for facilitating the tech transfer of client processes and executing engineering functions including design, scale-up document controls.

Essential Duties and Responsibilities:

• Develop batch records for client-specific formulation and filling operations. Oversee processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support, to facilitate process design and internal technology transfer.
  
• With senior/managerial engineering support, operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures that are assigned to process engineering. Direct client interaction for routine discussions, summarizing engineering-related work completed verbally as well as written. Client communication will be supported by more senior-level engineers, as needed
  
• Identify and specify process-specific equipment needed for clients' tech transfer, and develop techniques and process parameters specific to the clients' product while maintaining critical product attributes. Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
  
• Develop new manufacturing processes to meet client requirements. Adhere to safety requirements at all times. Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.
  
  Supervisory Responsibilities:
  
  This job has no supervisory responsibilities.
  
  Education and/or Experience:
  
  Bachelor's degree in Biology, Chemical Engineering, or related field. Minimum 12+ years experience in a cGMP/FDA regulated environment with experience with aseptic fill/finish.
  
  Reasoning Ability:
  
  Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  
  Computer Skills:
  
  To perform this job successfully, an individual should know spreadsheet software and word processing software. Experience with statistical software and drawing software is a plus.
  
  Other Skills and Abilities:
  
• Excellent communication skills. Meticulous and highly organized. Aseptic technique, familiarity with cleanroom personnel flows are desirable. Knowledge of process flows - e.g. Disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels is a plus.
  
• Working knowledge of process engineerings processing aids such as sanitary connections, valves, and pharmaceutical process design. Has a good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus). Ability to work with a moderate amount of supervision; interact well with clientele as well as interdepartmentally. Experience with statistically-based study designs and related software is a plus.
  
  Other Qualifications:
  
  Must pass a background check
  
  Must pass a drug screen
  
  Physical Demands:
  
  While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.
  
  Work Environment:
  
  While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.
  
  All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
  
  Note
  
  This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship.
  
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Keywords: Curia, New Haven , Senior Principal Process Engineer - ABQ, Engineering , Amityville, Connecticut