Process Engineer II

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. 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!

The Process Engineer II is responsible for facilitating the technology transfer of client processes and executing engineering functions including design, scale-up, 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 directly related to their project, in addition to providing training for new team members.

Essential Duties and 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 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 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
• Professionally communicate deviations to the 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 process engineering work experience
• Experience with aseptic fill/finish, preferred

Supervisory Responsibilities:

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

Language Skills:

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.

Mathematical 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.

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:

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.

Other Skills and Abilities:

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Ability to work with a moderate amount of supervision; interact well with clientele as well as interdepartmentally. This is a task-based role dependent on direction from internal Curia functions to execute, but the right candidate will take initiative and demonstrate understanding of strategic priorities
• Strong communication skills, as well as a meticulous and organized approach
• Familiarity with aseptic technique, familiarity with cleanroom personnel flows is desirable
• Knowledge of process flows – Disposable's strategies, filtration, mixing strategies, fluid transfer to and from various vessels is a plus
• Working knowledge of process engineering processing aids such as sanitary connections, valves, and pharmaceutical process design

Other Qualifications:

Must pass a background check

Must pass a drug screen

Must be able to 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 successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

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

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.