Manufacturing Specialist

Curia • Albuquerque, NM

10d

About The Position

Manufacturing Specialist 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 Specialist is the lead person for operations and manufacturing (i.e., vial prep, isolator, fill line operation and vial sealing) of parenteral products according to Current Good Manufacturing Practice (cGMP) in an aseptic environment. This role will train, coach/develop, and profivide timely feedback to team members. Responsibilities encompass: deliver production requirements, train operators to set up, operate, sanitize and sterilize equipment and manufacturing areas in a cleanroom setting. The Manufacturing Specialist ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency. The position also involves sanitizing aseptic and controlled areas using specialized solutions and equipment, following sanitization protocols during sterile processing of equipment, and complying with Standard Operating Procedures (SOPs) for all sanitization and documentation tasks.

Requirements

• Bachelor’s Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline
• Prior experience in a fill/finish GMP and/or cleanroom, preferred
• This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
• 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.
• 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.
• 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.
• 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.
• Ability to cultivate a culture of continuous improvement and right first-time quality
• 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
• 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
• 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.

Responsibilities

• Trains, coaches/develops, and provides timely feedback to team members
• Supports management with process support in the resolution of complex technical or operational problems
• Collaberates with management in the planning and managing day-to-day activities, including resource and task loading
• Follow Drug Enforcement Administration (DEA) regulations during controlled substance formulations
• Supports the timely processing and proper execution of d eviations, assessments, investigations & CAPA’s
• Oversee the preparation and sterilization 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
• Escalates issues/concerns in a timely manner as appropriate, to higher management
• Cross-functional collaboration with all levels
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties may be assigned

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 with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees