locations USA - North Carolina - Durham (Old Oxford) time type Full time posted on Posted Yesterday time left to apply End Date: December 11, 2024 (11 days left to apply) job requisition id R324434 Job Description 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. 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. Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator. The position will be Mon-Fri, Night Shift (10PM - 06:30AM). Successful completion of TB titer and Chest X-ray are required. Preferred Experience and Skills (General): Associates Degree in science or related field BioWork Certificate (working in an FDA or similar regulated industry) Applicable mechanical and project management experience Experience with automated systems (MES, SAP, DeltaV, or similar) Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP) Demonstrated ability to work both independently and as a part of a team Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. J-18808-Ljbffr