Process Engineer IV

Lake Pharma • Albuquerque, NM

34d

About The Position

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Process Engineer will be responsible for facilitating the tech transfer of client processes and executing engineering functions including design, and scale-up document controls. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. 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 Learning platform And more!

Requirements

• Bachelor's degree in Biology, Chemical Engineering, or a related field.
• Minimum eight (8) experience in a cGMP/FDA-regulated environment with experience with aseptic fill/finish.
• 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.
• To perform this job successfully, an individual should know spreadsheet software and word processing software.
• Excellent communication skills.
• Meticulous and highly organized.
• Must pass a background check
• Must pass a drug screen

Nice To Haves

• Aseptic technique and familiarity with cleanroom personnel flows are desirable.
• Knowledge of process flows - e.g. Disposables 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.
• Has a good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus).
• Ability to work with a moderate amount of supervision; interact well with clientele as well as interdepartmentally.
• Experience with statistically-based study designs and related software is a plus.
• Experience with statistical software and drawing software is a plus.

Responsibilities

• Develop batch records for client-specific formulation and filling operations.
• Oversee processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support, to facilitate process design and internal technology transfer.
• With senior/managerial engineering support, operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for 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 needed for clients' tech transfer, and develop techniques and process parameters specific to the client's product while maintaining critical product attributes.
• Author instructions for the operation of equipment and for detailing process flows in the cleanroom facility.
• Develop new manufacturing processes to meet client requirements.
• Adhere to safety requirements at all times.
• Raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.

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
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 101-250 employees