Project Manager - Capital Projects

Project Manager, CAPEX Responsibilities

The Project Manager, CAPEX is responsible for leading projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and implementation plans, including risk mitigation. They will perform the following objectives:

• Coordinate internal and external resources to ensure that projects adhere to scope, schedule, and budget.
• Analyze project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements can be met.
• Manage the CAPEX program for the site; to include cashflow forecasting, prioritization, commitments, tracking variances to budget, and facilitation of project governance.
• Establish and maintain relationships with relevant client stakeholders, providing day‑to‑day contact on project status and changes.
• Establish and maintain processes for managing scope during the project lifecycle, setting quality and performance standards, and assessing risks.
• Structure and manage integrated, multitrack performance databases for digital, print, social, broadcast, and experiential projects.
• Develop and maintain partnerships with third‑party resources, including vendors and researchers.
• Assign and monitor resources to ensure project efficiency and maximize deliverables.
• Report project outcomes and/or risks to the appropriate management channels and escalated issues as necessary, according to project work plan.
• Ensure alignment and coordinate with other functions such as Engineering, Validation, Maintenance, Manufacturing, MS&T, AFS, Process Development, and Quality Assurance. Supports efforts of the organization across functional boundaries.
• 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.
• Employee must have the ability to interface effectively with personnel across engineering, validation, maintenance, and other technical disciplines.
• Strong attention to deadlines and budgetary guidelines.
• Proven success working with all levels of management.
• Strong written and verbal communication skills.
• Excellent presentation skills.

• Ensuring adequate onboarding, support administration, and training for staff.
• Providing managerial support for staff working in cross‑functional teams.
• Providing technical 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.
• Facilitating staff development.

• Minimum of Bachelor’s degree in an engineering, or biochemical engineering discipline and 8+ years experience in the pharmaceutical/biotechnology field equivalent required and 5+ years management experience. Experience to include minimum of 5 years project management, 5 years GxP operations.
• Established knowledge of biopharmaceutical manufacturing, good engineering practices, and equipment design and qualification. Strong technical writing and communication skills.
• Proficiency with MS Project.
• Familiarity with MS Planner and Power BI.
• 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 cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate and escal risk is required.
• Demonstrated 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, Communication skills within all levels of an organization, Risk assessment and risk management, Project management including project delivery under aggressive timelines, Staff development and coaching.

• Background in Validation and Automation scope.
• PMP certification.
• LEAN / Six Sigma certification.

$114,000 - $156,750

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. 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.