Job Description

Manufacturing/Production Engineer I 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!

The Manufacturing Engineer plays a critical role within the manufacturing operations team and is assigned to a designated manufacturing shift. This position provides technical leadership and engineering support for the manufacture of sterile parenteral products in a controlled and aseptic environment, ensuring safe, compliant, and efficient operations. The Manufacturing Engineer partners with cross-functional teams to optimize manufacturing processes, improve equipment reliability and performance, resolve technical challenges, and support continuous improvement initiatives. This role requires a strong foundation in engineering principles, including equipment reliability, maintenance strategies, process optimization, and operational excellence, while maintaining a strong presence within manufacturing operations to support business needs.

Essential Duties and Responsibilities:

• Provide day-to-day technical and operational leadership for assigned manufacturing shift activities to ensure safety, quality, compliance, and production objectives are achieved
• Lead and support manufacturing operations involving vial preparation, isolator operations, aseptic filling, and vial sealing activities.
• Ensure production schedules and operational requirements are met through effective coordination of manufacturing activities.
• Train personnel on equipment setup, operation, sanitization, sterilization, and manufacturing processes within cleanroom environments.
• Participate in departmental and site training initiatives to maintain technical competency and support employee development.
• Drive activities and resolutions to improve process flow, safety, and overall production efficiency by identifying bottlenecks and fostering a culture of continuous improvement
• Identify and resolve complex manufacturing issues through collaboration with quality, engineering, and technical operations management
• Manages area of responsibility by ensuring compliance with cGMP standards, overseeing the proper operation and maintenance of equipment, and coordinating the sanitation and sterilization processes, as well as to maintain a controlled aseptic environment
• Ensures compliance with Drug Enforcement Administration (DEA) regulations during controlled substance formulations and verifies that staff adheres to these regulations
• Ensures the timely processing and proper execution of deviations, assessments, investigations & CAPA’s
• Manages the preparation and sterilization processes of equipment for clean rooms, product compounding, and filling according to the preparation list, to include disassembly and assembly
• Responsible for checking the recordings entered by employees of all procedures in logbooks as well as confirm complete/correct batch records according to cGDP
• Oversees the staff to complete the sanitization of aseptic/controlled production areas to ensure microbial contamination is reduced to a safe level on inanimate surfaces
• Conduct root cause analysis (RCA) for equipment failures and implement corrective and preventive actions (CAPA) to prevent recurrence
• Collaborate with cross-functional teams including manufacturing, quality assurance, and engineering to identify opportunities for process improvement and implement solutions
• Perform reliability assessments and develop key performance indicators (KPIs) to monitor and track equipment reliability and performance
• Lead reliability improvement projects to enhance equipment uptime, reduce downtime, and increase overall equipment effectiveness (OEE)
• Ensure compliance with regulatory requirements and industry standards related to equipment reliability and maintenance practices
• Provide technical expertise and support to manufacturing operations, troubleshooting complex technical issues as needed
• Stay informed about emerging technologies and industry trends in reliability engineering to identify opportunities for innovation and competitive advantage
• Assure associated documentation (including work orders and ECOs) are effectively and compliantly completed, updated, and maintained. Other duties as assigned
• Revise SOPs and documents as needed
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and/or Experience:

• Bachelor’s Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline
• One (1) year of experience supporting a manufacturing environment, preferred
• One (1) year of experience in a bio/pharmaceutical manufacturing environment, 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:

• 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
• Ability to organize time to successfully manage multiple projects and priorities
• Ability to read, understand, interpret and implement technical writing and instructions
• Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals
• Verbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style

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.