Process Engineer IV

Process Engineer IV in Albuquerque, NM

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!

Essential Duties and 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.

Supervisory Responsibilities:

This job has no supervisory responsibilities.

Education and/or Experience:

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.

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:

To perform this job successfully, an individual should know spreadsheet software and word processing software. Experience with statistical software and drawing software is a plus.

Other Skills and Abilities:

• Excellent communication skills. Meticulous and highly organized. 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.

Other Qualifications:

Must pass a background check

Must pass a drug screen

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use their hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.