MS&T Engineer II/III

Position Summary The MS&T Engineer II, III is responsible for providing technical support for cGMP runs, tech transfer activites, process engineering, process validation, process monitoring, and biopharmaceutical processes in the cGMP manufacturing facility. The MS&T Engineer interfaces with client organizations to enable clear process description and requirement definition for site implementation. The MS&T Engineer is also responsible for supporting equipment system ownership activities such as procuring and enrolling manufacturing equipment, defining equipment maintenance requirements, equipment commissioning and qualification activities, and evaluating deviations and change impacts. The MS&T engineer is responsible for working cross-funictionally with manufacturing, validation, QA, Facilities & Engineering, Supply Chain, IT, Automation, QC, Process Development as necessary to ensure process implementation and execution is validated and compliant. Position Responsibilities Support technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection Prepare/review technical documents including supporting batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications Support technical deviation investigations and collaborate with operations, technical and quality management to determine event impact, perform root-cause analysis and corrective action identification Compile and analyze process data and communicate to client and upper management via production updates and campaign summary reports Supporting/leading collaboration on strategic projects or studies with external & internal partners and presents results in technical reports Assist with Bill of Material (BOM) generation for new process introductions as well as updating BOMs for process modifications Author Material Specifications in accordance with compendia requirements and grade requirements for introduced process Author, qualify, and manage Unicorn methods Present and defend procedures, validation, and exceptions in audits and inspections Position Requirements Engineer II: BS in Science or Engineering with minimum of 4 years industry experience or Masters with 2 years industry experience Engineer III: BS in Science or Engineering with minimum of 7 years industry experience or Masters with 5 years industry experience Previous work in downstream manufacturing practices and methodologies, including UFDF, chromatography, purification, etc. Salary: Engineer II $80,000-$95,000 Engineer III: $100,000-$115,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results. 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.

Salary : $80,000 - $95,000