Director, Project Engineering

Job Summary:

The Project Director is responsible for leading, primarily strategic, CAPEX projects and programs from requirements definition and business case assessment through handover to the relevant operating unit. Tasks include developing and executing Project Charters, Project Plans, schedules, scopes, budget estimations, and implementation plans, including meeting all quality assurance and compliance requirements, and project risk management.

Job Responsibilities:

Perform the following site and strategic CAPEX project- and program-related objectives:

• Develop business case assessments, options analyses, and feasibility studies for both site and strategic corporate programs and projects.
• Provide project management input and generate deliverables for strategic KBI initiatives.
• Coordinate internal and external resources to ensure that projects adhere to scope, schedule, and budget and all individual project tasks are completed in a technically adequate manner.
• Analyze project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements can be met.
• Establish and maintain relationships with relevant client stakeholders, providing day-to-day contact on project status and changes.
• Establish and maintain fit-for-purpose processes, procedures, tools, and guidelines for managing scope, cost and schedule during the project or program lifecycle, setting quality and performance standards, and assessing risks.
• Develop and maintain strategic partnerships with approved third-party resources, including vendors and service providers.
• Assign and monitor resources to ensure project efficiency and maximize deliverables.
• Report project outcomes and/or risks to the appropriate management channels and escalate issues, as necessary, according to project work plan.
• Ensure alignment and coordinates with other functions such as Engineering, Validation, Maintenance, Manufacturing, Manufacturing Sciences, Microbiology, Process Development, Business Development, Corporate Strategy and Quality Assurance. Supports efforts of both the site and corporate organization across functional boundaries.
• Ensure projects meet all quality assurance and compliance, federal, state, and local regulation and EHS&S requirements both in terms of scope and means of execution.
• Provide technical decision-making regarding project implementation strategies as well as requirements for projects and change controls.
• Provide exceptional customer service to internal and external clients.
• Develop cost- and resource-effective project and program processes, tools, and practices.
• Employee will actively manage a team of KBI employees and contractors. This includes the following:
  • The development and leadership of cross-functional high-performing project teams.
  • Ensuring adequate onboarding, support administration, and training for staff.
  • Providing managerial support for staff working in cross functional teams.
  • Providing technical and leadership guidance to ensure work is completed in a compliant and efficient manner.
  • Ensuring adequate resource management to ensure projects are adequately staffed with trained team members and that staff can maintain work life balance.
  • Facilitate staff development.
• The Project Director will develop and manage the CAPEX Program for the site including cashflow forecasting, prioritization, commitments, tracking variances to budget, facilitation of project governance and timely and successful project CAPEX Application Request (CAR) funding

Job Requirements:

• Minimum of bachelor’s degree in an engineering, or biochemical engineering discipline and 15+ experience in the pharmaceutical/biotechnology field equivalent required and 10+ years management experience. Experience to include minimum of 10 years project management, 10 years cGxP operations.
• Established knowledge of current project management practices and tools, biopharmaceutical manufacturing, good engineering practices, and equipment design and qualification. Strong technical writing and communication skills.
• Ability to use negotiation skills drive to resolution on critical issues. Ability to summarize issues and present to executive management.
• A broad understanding of applicable codes and regulations. Knowledge of Quality Systems and cGXP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to ensure that projects and programs successfully meet those requirements.
• Demonstrated successful track record in the following key areas:
  • Strong problem-solving capacity.
  • Results orientation.
  • Strong communication and presentation skills.
  • Strong orientation for quality and customer service.
  • High level of integrity and personal responsibility.
  • Good communication skills within all levels of an organization.
  • Risk identification, assessment, management and mitigation.
  • Ability to escalate appropriate risk concerns.
  •  Project management including successful project delivery against aggressive schedules.
  • Project management in a highly regulated environment including, specifically, cGxP requirements.
  • Developing fit-for-purpose project and program management policies, process, procedures, KPI’s / metrics and guidelines.
  • Staff development and coaching. Contractor management.

Additional Preferred Qualifications:

• Background in Validation and Automation scope.
• Project Management Professional (PMP)® certification.
• LEAN / Six Sigma certification.

Language Ability

• Ability to, in the English language, read and interpret regulatory documents and industry technical papers, technical documents, schematic drawings, P&IDs, engineering specifications, proposals, invoices, contracts, safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write technical documents and communication documents.
• Ability to speak effectively before internal groups or employees of organization and external clients and inspectors.

Reasoning Ability

• Ability to independently solve complex problems with minimal supervision and deal with a variety of concrete variables in situations where limited data may exist.
• Strong time management skills and an ability to multitask in a face paced environment.
• Ability to deliver consistent high-quality work products.
• Ability to manage multiple projects and to work well within a team environment.

Math Ability

• Ability to add, subtract, multiply, divide, and convert in all units of measure, using whole numbers, common fractions, and decimals.
•  Problem solving and application of engineering skills.

Physical Demands

• Minimal physical demands lifting and carrying up to 25 lbs.

Computer Skills

• MS Office suite, electronic document/info management systems, engineering software tools.
• MS Excel spreadsheet creation and data analysis functions.
• Proficiency with MS Project.
• Familiarity with MS Planner and Power BI.
• Effective user of GXP-compliant software systems.
• Use of project management tools, e.g., MS Project.

Equipment Use

• Working knowledge and awareness of safety factors related to facility/utility support equipment (HVAC; Purified Water; Clean Steam, and Clean Process Air); unit operations process equipment (fermenters; filtration skids), process support equipment (sterilizers, washers); computerized workstations.

WORKING CONDITIONS: Work occasionally requires construction, commissioning, qualification, and shutdown activities to occur outside of 1st shift hours (8AM-5PM) to accommodate the availability of work areas, and equipment/systems in support of the manufacturing-related activities schedule. Work responsibilities will also include planning, coordinating and leading the execution of multiple ‘in the field’ work processes. All safety training is required to be complete, and risks reviewed prior to performing work. As required, trained support is available to assist with tasks to ensure a safe work environment.

Salary Range: $173,000.00 - $238,700.00

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.  

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. For more information, visit www.kbibiopharma.com. 

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. 

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.