Responsible for technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility. Job Responsibilities: New Product/Process Introduction and Changes including: Facility Fit support Manufacturing Record and procedure drafting Equipment procurement or modification Training generation Drafting, routing, and revision of manufacturing batch records, procedures, supporting records. Serve as technical SME in manufacturing operations, coaching manufacturing associates, supporting trainers in development of TRNs Manufacturing process support during on-going shop floor execution. Engage with Manufacturing Associates and Supervisors to understand barriers to success, identify opportunities for improvement. Drive and manage projects with significant process improvement impact Lead implementations for corrective and preventive actions. Partner with Compliance/QA for timely Deviation Investigation completion Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing Support safety initiatives, compliance & quality requirements. Minimum Requirements: Demonstrated knowledge of downstream operations, cell culture and/or fermentation Experience in single-use platform technology is preferred Bachelor’s degree in a related scientific or engineering discipline preferred with 1+ year’s related experience and/or training; or equivalent GMP manufacturing experience Requires minimal direction or supervision to execute against routine tasks. Fluent in English with excellent written and verbal communication skills are required. Must be detail oriented, have good time management skills and be customer focused Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. Working Conditions The job requires supporting a 24-hour manufacturing facility which may include on call phone support or support overnight and on weekends. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee may use equipment and materials which include mechanical hazards, chemical hazards, electrical hazards, and tripping and falling hazards. The noise level in the manufacturing environment is moderate to high, however, employee will routinely work in office area. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal. At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged. If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently. Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to staffinginquiry@kbibiopharma.com. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.

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