Process Engineer II

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Process Engineer II

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Curia

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.

Overview

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.

Summary

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.

Responsibilities

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

Education And Experience

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

Supervisory Responsibilities

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

Skills And Qualifications

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

Other Qualifications

Must pass a background check

Must pass a drug screen

Must obtain and maintain gowning certification

May be required to obtain and maintain media qualification

May be required to wear a respirator

Physical Demands

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. All positions may require lifting and moving up to 50 pounds infrequently, with other activities involving standing, walking, and manual dexterity. Some roles may involve climbing and working at elevated heights.

Work Environment

The work environment will vary and may include office, manufacturing, or warehouse settings. The pharmaceutical manufacturing environment is sterile and aseptic gowning is required. PPE (gloves, cleanroom socks, face shields, safety glasses, aprons, steel-toed shoes, PAPRs) may be required depending on tasks. Employees may be exposed to wet / humid conditions, refrigerated environments, and moving mechanical parts. All environments may involve exposure to cleaning agents.

Equal Opportunity Statement

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, protected veteran status, or disability. Curia is an E-Verify employer.

Job Details

Seniority level : Mid-Senior level

Employment type : Full-time

Job function : Management and Manufacturing

Industries : Pharmaceutical Manufacturing

We do not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. All resumes submitted without a valid signed search agreement will be the property of Curia.

All interested applicants must apply online.

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