Easter Seals Jobs

Process Engineer III in Albuquerque, NM

The Process Engineer III is responsible for facilitating the technology transfer of multiple client processes and executing engineering functions including design and scale-up document controls. This role functions as a program lead. The Process Engineer III provides guidance and instruction to supporting team members on tasks directly related to their project, in addition to providing guidance and instruction on site-driven projects.

Essential Duties and Responsibilities:

• Leads batch record and 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 (e.g. CAPA, departures, CCRs) from initiation to closure. 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.

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

  Education and Experience:

• Bachelor’s degree in Biology, Chemical Engineering, or related field of study

• Minimum of five (5) years’ experience in Pharmaceutical, Biotech or related industry

• Minimum of five (5) years’ experience in a cGMP/FDA-regulated environment

• Experience with aseptic fill/finish

• Advanced degree and seven (7) or more years of experience providing technical support, or working in a cGMP/FDA-regulated environment with 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.

  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

• Able to work independently to balance completing individual tasks and drive projects to completion.

• Excellent communication skills. Meticulous and organized.

• Familiarity with aseptic technique, 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.

  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.

  The essential physical demands will vary for each Curia position.

  All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

  Work Environment:

  The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

  The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

  The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

  The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

  Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

  All environments may be subject to working with or being exposed to cleaning agents.

  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.