Manufacturing Specialist in Albuquerque, NM

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

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.

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.

Essential Duties and Responsibilities:

• Trains, coaches/develops, and provides timely feedback to team members

• Represents Manufacturing in leadership meetings to support dedicated areas of responsibility

• Revise SOPs and documents as needed

• 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

• 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

Education and Experience:

• Bachelor’s Degree in Mechanical Engineering, Biochemical Engineering, Chemical Engineering, or related discipline

• Prior experience in a fill/finish GMP and/or cleanroom, preferred

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.

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

• 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

  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.