Technician, Operations USA - North Carolina - Durham (Old Oxford)

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. This position will be a part of the Drug Product team, focusing on product filling and lyophilization. The position will initially be Mon-Fri, day shift, transitioning to second shift as required when operations starts, expected in late 2023.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. 

Responsibilities may include but are not limited to:

Project Support:

• Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility. 

• Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations. 

• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel. 

• Actively participate in team meetings HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. 

Operational Expertise: 

• Competent execution and ownership to meet production targets for area within responsibility including: 

• Attending and escalation of concerns or needs at daily huddles and as needed 

• Cleaning, setup, operation and troubleshooting of equipment and facilities 

• Maintenance and transportation of consumable and material inventories 

• Maintenance of excellent recordkeeping and housekeeping 

• Drives culture of continuous improvement. Implements and raises ideas to increase success of group 

• Participates on and/or performs activities to support technical and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol execution. 

• Maintains detailed knowledge of equipment and processes. 

• Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel. 

Education Minimum Requirement:  

• High School Diploma/GED or higher 

Required Experience and Skills:  

• At least one (1) year GMP manufacturing/processing experience 

• Demonstrated written and verbal communications skills 

• Must be able to successfully pass and maintain aseptic gowning qualifications. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots. 

• Computer literacy (internet browsers, e-mail, spreadsheet