Process Engineer IV

Curia • Albuquerque, NM

9d

About The Position

Process Engineer IV 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. 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 Learning platform And more! Summary: The Process Engineer IV will execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control. This position will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Production, providing technical leadership and expertise to drive process improvements, enhance operational efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations.

Requirements

• Bachelor’s degree in Biology, Chemical Engineering, or a related field
• Minimum eight (8) years’ experience in a cGMP/FDA, regulated environment
• The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.
• 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.
• 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

Nice To Haves

• Experience with aseptic fill/finish, preferred

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 client's 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.

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
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees