Senior Project Engineer

The Sr. Project Engineer is responsible for design and implementation of process and/or utility systems of a GMP biopharmaceutical manufacturing and development facility. The engineer collects requirements, develops design deliverables, procures equipment, and implements changes. The Sr. Project Engineer supports capital projects to establish new capabilities or to modify / improve existing capabilities. With a strong technical understanding of the equipment and systems, the engineer develops and maintains design documents, drawings, reports; ensures designs meet requirements. The engineer follows project delivery process throughout the project lifecycle from project initiation through qualification. The project engineer ensures design is reviewed with key stakeholders. The engineer supports development of capital plans and improvements; engineering specifications and standards; and improvement project delivery processes. The engineer may lead cross-functional projects of moderate scope and guide the successful completion of programs. May be expected to mentor other engineers and directly supervise staff and/or project resources. The engineer collaborates and coordinates with other functions such as Project Management, A&E service providers, System Engineering, Validation, Maintenance, Manufacturing, Process Development, and Quality Assurance. Represents the his/her designs to the user team and clients, and stakeholders.

• Leads activities associated with planning and engineering design from concept, basic, and detail design phases. Provides engineering support for equipment procurements, acceptance, installation, construction, commissioning, and qualification. Includes oversight of contract engineering team(s).
• Leads activities associated with procurement of engineering services and equipment. This includes develop of scope of work, specifications, data sheets, RFP/RFQ, technical bid tabulation, submittals, and factory and site acceptance.
• Develops, supports, and manages project documents, site standards, site specifications, and turnover documentation
• Support development of capital plans by performing feasibility studies and support business cases.
• Oversee work of independent contractors, as appropriate, and ensures all project specifications/requirements/codes are met while work is being performed on-site.

Minimum Requirements:

• B.S. in Chemical Engineering or Mechanical Engineering

Experience:

• A minimum of 8 years of engineering and project management experience

• A minimum of 4 years of experience in the pharmaceutical industry in engineering or project management
• Strong knowledge of cGMP manufacturing processes and related codes and regulations
• Comprehensive biopharma processes and/or utilities unit operation expertise.
• In-depth knowledge of validation practices and associated regulatory expectations.

Additional Preferred Qualifications:

• Experience with Therapeutic Proteins
• Pharmaceutical facilities design experience in an engineering consulting firm
• Design and construction of cGMP systems
• Management of small projects
• Position may require travel to support projects at other sites.

Salary Expectation: 112,000- 140,000K 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.