Process Engineer II
On-siteAlbuquerque, New Mexico, United States
Job Summary
Develop batch records and lead process activities for client-specific formulation and filling operations, overseeing critical engineering and GMP tasks including equipment preparation, bulk product formulation, sterile filtration, and filling support. Act as subject matter expert for GMP investigations from initiation to closure, finalizing closure reports for assigned departures while identifying and specifying process-specific equipment based on facility and program needs. Author operation instructions and process flow details in the cleanroom facility, develop new procedures, and provide training on SOPs, work instructions, and client programs. Communicate deviations to appropriate leaders and interact directly with clients to summarize engineering work. Adhere to safety requirements and maintain up-to-date training certifications.
Required Qualifications
- 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
- Must pass a background check
- Must pass a drug screen
- Must be able to obtain and maintain gowning certification
- Must be able to obtain and maintain media qualification
- Must be able to obtain and maintain respirator certification
- 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
- 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
- Proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook
- Ability to work with a moderate amount of supervision
- Ability to interact well with clientele as well as interdepartmentally
- Meticulous and organized approach
- Familiarity with aseptic technique
- Familiarity with cleanroom personnel flows
- Knowledge of process flows – Disposable's strategies, filtration, mixing strategies, fluid transfer to and from various vessels
- Working knowledge of process engineering processing aids such as sanitary connections, valves, and pharmaceutical process design
- Ability to lift 10 pounds frequently
- Ability to lift 25 pounds occasionally
- Ability to lift 50 pounds infrequently
- Ability to sit, stand, and reach
- Visual acuity, both close and distant, along with depth perception
- Hand and finger dexterity
- Ability to stoop, kneel, twist, crouch, crawl, and balance
- Ability to climb and work at elevated heights
Desired Qualifications
- Experience with aseptic fill/finish, preferred
- Knowledge of process flows – Disposable's strategies, filtration, mixing strategies, fluid transfer to and from various vessels is a plus
- 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
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