Manufacturing Engineering Technician

Manufacturing Engineering Technician in Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

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 with matching contributions

• Learning platform

• And more!

Summary:

The Manufacturing Engineering Technician provides technical and operational support for the manufacture of sterile parenteral products in a controlled and aseptic environment. This role supports manufacturing operations by ensuring compliance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements while promoting safe, efficient, and compliant production activities. The Manufacturing Engineering Technician partners closely with Manufacturing Engineering, Quality, and Operations personnel to support equipment readiness, manufacturing processes, troubleshooting efforts, personnel development, and continuous improvement initiatives. This position requires strong technical aptitude, attention to detail, and the ability to maintain a consistent presence within manufacturing operations to support business needs.

Essential Duties and Responsibilities:

• Serve as the process lead within assigned manufacturing areas, providing technical guidance and ensuring manufacturing activities are executed safely, compliantly, and in accordance with approved procedures.

• Support manufacturing operations involving vial preparation, isolator operations, aseptic filling, and vial sealing activities.

• Assist in meeting production schedules and manufacturing objectives through effective execution and coordination of assigned operational activities.

• Partner with Manufacturing Engineers to support manufacturing operations, equipment performance, process improvements, and issue resolution.

• Identify and resolve manufacturing process issues through collaboration with Quality, Engineering, and Technical Operations personnel.

• Manage assigned areas of responsibility by ensuring compliance with current Good Manufacturing Practices (cGMP), company procedures, and regulatory requirements while maintaining a controlled aseptic manufacturing environment.

• Ensure compliance with Drug Enforcement Administration (DEA) regulations during controlled substance manufacturing activities and verify adherence to applicable requirements.

• Provide process-specific training and technical instruction on equipment setup, operation, sanitization, sterilization, aseptic techniques, and cleanroom manufacturing practices.

• Manage the preparation, assembly, disassembly, cleaning, sanitization, and sterilization of equipment used in cleanroom, compounding, and filling operations in accordance with approved procedures and production schedules.

• Perform and oversee the sanitization of aseptic and controlled manufacturing areas using approved disinfectants, cleaning agents, equipment, and procedures to reduce microbial contamination to acceptable levels.

• Follow sanitization protocols during sterile processing activities and ensure manufacturing areas and equipment are maintained in a state of cleanliness and readiness for production.

• Review manufacturing documentation, logbooks, and batch records for accuracy, completeness, and compliance with current Good Documentation Practices (cGDP).

• Maintain accurate and complete documentation associated with manufacturing, sanitization, sterilization, and production activities in accordance with cGDP requirements.

• Read, interpret, and comply with Standard Operating Procedures (SOPs), work instructions, batch records, and other controlled documentation to ensure compliance with cGMP requirements.

• Escalate operational, quality, safety, equipment, and compliance concerns to manufacturing supervision in a timely manner.

• Participate in training and continuous improvement initiatives to enhance manufacturing processes, productivity, quality, compliance, and operational efficiency.

• Maintain qualification requirements, including gown qualification and validation for Grade A aseptic manufacturing environments.

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

Education and/or Experience:

• High school diploma or general education degree (GED)

• Associate’s Degree in Engineering, Engineering Technology, or related discipline, preferred

• Two (2) years prior experience in a fill/finish GMP and/or cleanroom, preferred

Supervisory Responsibilities:

This role does not have supervisory responsibilities, yet it may involve being a lead person for operations and manufacturing, 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:

• Ability to cultivate a culture of continuous improvement and right first-time quality

• 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

Other Qualifications:

• Must pass a background check

• Must pass a drug screen

• May be required to pass Occupational Health Screening

• Must be able to obtain and maintain gowning certification

• Must be able to obtain and maintain media qualification

• Must be able 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 in some areas 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.