Process Engineer II

Curia • Albuquerque, NM

13h • Onsite

About The Position

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.

Requirements

• 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
• Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, along with effective presentation skills.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• 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.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• 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.
• Strong communication skills, as well as a meticulous and organized approach
• Working knowledge of process engineering processing aids such as sanitary connections, valves, and pharmaceutical process design
• 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

Nice To Haves

• Experience with aseptic fill/finish, preferred
• 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

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

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 with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level