The Capital 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.
Responsibilities:
The Project Engineer supports capital projects to establish new capabilities or to modify improve existing capabilities.
The project engineer ensures design is reviewed with key stakeholders.
The engineer follows project delivery process throughout the project lifecycle from project initiation through qualification.
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.
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.
Requirements:
B.S. in Chemical Engineering or Mechanical Engineering.
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.
Salary Range:
$118,000 - $162,800
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.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
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Senior Project Engineer