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Job Description
Manufacturing Specialist in Albuquerque NM
Build your future at Curia where our work has the power to save lives.
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 provide 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.
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!
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 & CAPAs
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
Additional Qualifications/Responsibilities
Education and Experience:
Bachelors 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 organizations 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.
Required Experience:
Unclear Seniority