Biologics Manufacturing Technician

AbbVie • Kansas City, MO

274d

About The Position

We are now recruiting experienced Manufacturing Technicians to join our New Product Introduction team in AbbVie Westport, Co Mayo. As our new Manufacturing Technician, you will be responsible for all manufacturing activities necessary to support a tech transfer of a NPI to accommodate clinical manufacture of small and large molecule products. Your new duties will involve (1) Manufacturing, (2) Biologic Drug Product commercial support, and (3) New Product Introduction/Project Management. As part of a team, you will be responsible for ensuring that drug product manufacturing is performed in compliance with site and GMP procedures, and that scheduling and manufacturing meets global request timelines. Flexibility around shifts is required, as this will be a 12 hour shift based role, with monthly rotational shift pattern, covering days and nights and weekends.

Requirements

• 3rd level qualification in relevant discipline and/or 12-18 months minimum experience in the pharmaceutical or medical device industry.
• Experience working in cleanroom environments essential.
• Prior knowledge of aseptic practices desirable.
• Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing and validation is desirable.
• Understanding of autoclave sterilization, depryogenation, and filter integrity testing is desirable.
• Knowledge of lyophilization and freeze dryer operations is desirable.
• Experience with single use technologies is desirable.
• Well-developed technical writing, organisational, and communication skills are essential.
• Experience working in project and team-based environments is essential.
• Pro-active approach with proven problem-solving skills is desirable.

Responsibilities

• Manufacturing of pharmaceutical products at different stages of lifecycle including clinical, non-clinical and pre-clinical material.
• Batch preparation activities (vial washing, load sterilization, area preparation).
• Work aseptically or as required by the classification of the production area(s).
• Perform compounding, sterile filtration and sterile filling activities.
• Work with various vendors on the development/improvement of new and existing systems regarding single use technologies.
• Prepare components and equipment for processing into Grade A environments.
• Aid in running a multi-product suite, changing between different product campaigns without issue.
• Perform environmental monitoring.
• Comply with Good Manufacturing Practices (GMP) and with Standard Operating Procedures (SOPs).
• Review and contribute to technical documents, including protocols, reports and batch manufacturing documents.
• Participate in cross-functional teams with other functions, including R D, Engineering, Quality, Supply Chain, Operations and Validation.
• Adhere and support all EHS standard procedures and policies.

Benefits

• Great benefits
• Defined career path
• Work-life balance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree