Process Engineer II - Albuquerque, NM

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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!

Summary :

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

Certificates / Security Clearances / Other

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.

Additional Qualifications / Responsibilities

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.