Process Engineer III

CuriaAlbuquerque, NM
9d

About The Position

Process Engineer IV in Albuquerque, NM Build your future at Curia, where our work has the power to save live. The Process Engineer III is responsible for facilitating the technology transfer of multiple client processes and executing engineering functions including design and scale-up document controls. This role functions as a program lead. The Process Engineer III provides guidance and instruction to supporting team members on tasks directly related to their project, in addition to providing guidance and instruction on site-driven projects. 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. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. We proudly offer Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more!

Requirements

  • Bachelor’s degree in Biology, Chemical Engineering, or related field of study
  • Minimum of five (5) years’ experience in Pharmaceutical, Biotech or related industry
  • Minimum of five (5) years’ experience in a cGMP/FDA-regulated environment
  • Experience with aseptic fill/finish
  • Must pass a background check
  • Must pass a drug screen
  • May be required to pass Occupational Health Screening
  • May be required to obtain and maintain gowning certification
  • May be required to obtain and maintain media qualification
  • May be required to wear a respirator
  • The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.
  • Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.
  • 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.
  • The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Nice To Haves

  • Advanced degree and seven (7) or more years of experience providing technical support, or working in a cGMP/FDA-regulated environment with experience with aseptic fill/finish, preferred

Responsibilities

  • Leads batch record and 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 (e.g. CAPA, departures, CCRs) from initiation to closure.
  • 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 based on facility, client, and program needs.
  • Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
  • Develop new procedures to meet facility and client requirements.
  • Adhere to safety requirements at all times.
  • Designs and provides training on operation tasks, like those captured in SOPs or work instructions.
  • Provides training on client programs and processes.
  • Read/interpret SOPs to ensure compliance
  • Maintain up to date trainings
  • Other duties as assigned

Benefits

  • Generous benefit options (eligible first day of employment)
  • Paid training, vacation and holidays (vacation accrual begins on first day of employment)
  • Career advancement opportunities
  • Education reimbursement
  • 401K program with matching contributions
  • Learning platform
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