Kbi: US - Manufacturing Sciences Engineer I, II, III

Job summary

The MS&T Engineer I, II, III (MS&T Engineer) is responsible for providing technical support for cGMP production runs, tech transfer activities, 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-functionally 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.

The progression from Engineer I through III includes assignments of increasing complexity and less supervision.

Job Responsibilities

Responsibility

Approximate % of Time

Support technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection

10%

Prepare / Review technical documents including supporting batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications

10%

Support technical deviation investigations and collaborate with Operations, Technical and Quality Management to determine event impact, perform root-cause analysis and corrective action identification

10%

Compile and analyze process data and communicate to client and upper management via production updates and campaign summary reports

20%

Supporting/leading collaboration on strategic projects or studies with external & internal partners and presents results in technical reports

10%

Assist with Bill of Material (BOM) generation for new process introductions as well as updating BOMs for process modifications

10%

Author Material Specifications in accordance with compendia requirements and grade requirements for introduced process

10%

Author, Qualify and Manage Unicorn methods

10%

Present and defend procedures, validation and exceptions in audits and inspections

10%

Total:

100%

Minimum Requirements

Knowledge, Skills, Abilities

Level

Minimum Requirement

Engineer I

BS in Science or Engineering with minimum of 2 years industry experience or Masters with no industry experience or equivalent education and experience

Engineer II

BS in Science or Engineering with minimum of 4 years industry experience or Masters with 2 years industry experience or PhD with no years industry experience or equivalent education and experience

Engineer III

BS in Science or Engineering with minimum of 7 years industry experience or Masters with 5 years industry experience or PhD with 3 years industry experience or equivalent education and experience

Language Ability

Fluent in reading and writing the English language. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and batch production records.

Ability to write routine reports. Ability to speak effectively before groups of customers or employees.

Reasoning Ability

Ability to solve practical problems or deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

Math Ability

Ability to develop and solve algebraic and exponential math problems by hand or using software. Ability to apply statistical methods to data sets and develop, interpret, and present results for investigations and reports.

Physical Demands

Reference working conditions below.

Computer Skills

MS Office, ERP, Quality Systems, statistical software, Process Control Systems, LIMS, other

Equipment Use

Computer, telephone, copy machine/printer

Working Conditions

Are there particular working conditions associated with this position that should be noted (i.e., working environment, hours of work, travel, work space, etc.)?

Yes

No

If yes, please explain:

The job requires working typical business hours but may also require off-hour manufacturing support. The job requires the ability to work in a cGMP manufacturing biotechnology facility with 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 will utilize equipment and materials which may include mechanical, chemical, electrical and/or tripping/falling hazards.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.