Senior Process Engineer

2 weeks ago

Albuquerque, New Mexico, United States curiate Full time
Job Overview

Position: Senior Process Engineer

Company: Curia

Location: Albuquerque, NM

Curia is a leading provider of contract research and manufacturing services to the pharmaceutical and biotechnology sectors. We are seeking a Senior Process Engineer to manage and implement sophisticated engineering tasks such as process architecture, scaling operations, and comprehensive documentation oversight. This role will work in tandem with diverse teams, including Research & Development, Quality Assurance, and Production, delivering technical guidance and expertise to enhance process efficiencies, improve operational workflows, and ensure adherence to industry standards, including cGMP and FDA regulations.

Key Responsibilities:
  • Formulate batch records tailored to client-specific formulation and filling processes. Supervise operational activities (ENG and GMP) including equipment setup, bulk product formulation, sterile filtration, and filling assistance to support process design and internal technology transfer.
  • Act as a Subject Matter Expert (SME) for GMP investigations with senior engineering support, including CAPA, deviations, and closure reports related to process engineering. Engage in direct client communication for routine updates, articulating engineering-related activities both verbally and in writing, with assistance from senior engineers as necessary.
  • Identify and specify the equipment necessary for client technology transfers, developing techniques and process parameters that align with client product specifications while preserving critical product characteristics. Create operational instructions for equipment and document process flows within the cleanroom environment.
  • Innovate new manufacturing processes to fulfill client needs while strictly adhering to safety protocols. Report any process deviations to the shift supervisor, engineering manager, or quality assurance.
Qualifications:
  • Bachelor's degree in Biology, Chemical Engineering, or a related discipline.
  • A minimum of eight (8) years of experience in a cGMP/FDA regulated environment.
  • Experience in aseptic fill/finish processes is preferred.
Supervisory Role:
This position does not entail supervisory duties but may involve mentoring and advising junior staff.

Language Proficiency:
The ideal candidate should possess the ability to read and interpret various documents, including safety guidelines, standard operating procedures, technical instructions, and regulatory materials. Strong written and verbal communication skills, along with effective presentation capabilities, are essential.

Mathematical Competence:
Proficiency in performing arithmetic operations, including addition, subtraction, multiplication, and division across various units of measurement, is required. A solid understanding of algebraic and geometric principles is necessary.

Analytical Skills:
The ability to identify problems, gather data, establish facts, and draw valid conclusions is crucial. Candidates should be able to interpret a wide range of technical instructions in both mathematical and diagrammatic forms, managing multiple abstract and concrete variables.

Technical Skills:
The successful candidate will have a robust technical background and proven experience in utilizing various software tools to enhance organizational efficiency. Essential skills include proficiency in manufacturing software and Microsoft Office applications such as PowerPoint, Excel, Word, and Outlook.

Additional Requirements:
Successful candidates must pass a background check and drug screening. They may also be required to undergo Occupational Health Screening and maintain gowning certification.

Physical Requirements:
The physical demands outlined here represent those that must be met by an employee to effectively perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to fulfill these functions.

Work Environment:
The characteristics of the work environment described below are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Curia offers a dynamic work environment that may include office, manufacturing, or warehouse settings. The office is designed for comfort and productivity, while the manufacturing area is sterile, requiring aseptic gowning. Personal protective equipment is necessary based on the tasks performed.

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 on the basis of disability. Curia is an E-Verify employer.

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