Vice President, Facilities & Engineering

KBI Biopharma•Durham, NC

About The Position

The Vice President, Facilities and Engineering is responsible for the performance of buildings, equipment, and systems at a cGMP manufacturing facility. This role leads, manages, and coaches engineering, validation, maintenance, and capital project staff to ensure equipment and systems are properly designed and installed, and consistently perform as intended. The Vice President develops a high-performing team and promotes a culture of safety, quality, and KBI core values. The role develops strategies, processes, systems, procedures, and metrics to support facility and equipment availability, reliability, and performance; monitors work orders, change controls, qualification status, and readiness; and manages engineering processes associated with new product introductions. It directs and implements controls and systems for Plant Engineering, Facilities, Maintenance and Calibration, Validation, and CAPEX project functions. The Vice President coordinates with site functions including Finance, Manufacturing, MS&T, QC Analytical/Laboratories, and Quality Assurance, and works across functional boundaries in a matrixed organization. The role represents Facilities & Engineering to clients, auditors, and inspectors; oversees engineering support for multiple systems, processes, or areas; develops subject matter experts; and directs, reviews, and approves engineering documents. It also supports monthly reporting on overall status, key issues, and performance KPIs. The position provides technical decision-making on project implementation strategies and project and change-control requirements, including ownership of risk assessments, plans, and procedures and review and approval of team members’ work. It requires effective service to internal and external clients and effective collaboration across quality, validation, maintenance, and other technical disciplines, with knowledge of quality systems and cGMP requirements across regulatory jurisdictions including FDA, EU, and ICH.

Requirements

Bachelor’s degree in an engineering discipline such as mechanical, electrical, chemical, or biomechanical engineering.
At least 15 years of engineering experience, including at least 10 years in the biotech industry and 5 years of management experience.
Established expertise in biopharmaceutical manufacturing, good engineering practices, and equipment design and qualification.
Strong technical writing and communication skills, including the ability to summarize complex issues for executive management.
Ability to negotiate and drive critical issues to resolution.
Broad understanding of applicable codes and in-depth working knowledge of cGMP requirements and regulations.
Strong orientation toward quality and customer service, integrity, and personal responsibility.
Ability to communicate with people at all levels of an organization and align growth requirements with profit objectives.
Experience with risk assessment and risk management, project management and delivery under aggressive timelines, and staff development and coaching.
Ability to read and interpret regulatory and technical documents, schematic drawings, P&IDs, engineering specifications, safety rules, operating and maintenance instructions, procedure manuals, and batch and production records in English.
Ability to write technical and communication documents, reports, and clearly communicate with executive management, employees, government agencies, customers, and inspectors.
Ability to solve practical problems independently with minimal supervision and make decisions when data is limited.
Ability to apply engineering principles and interpret federal, state, and local code requirements.
Strong time-management and multitasking skills, attention to detail, and ability to produce thorough documentation consistent with SOP requirements.
Ability to understand complex technical concepts and communicate them clearly in text and graphics.
Ability to manage multiple projects and work effectively in a team environment.
Ability to perform basic arithmetic and unit conversions, apply engineering problem-solving skills, calculate rates, ratios, and percentages, and interpret bar graphs.
Minimal physical demands, including lifting and carrying up to 25 pounds.
Computer skills with the MS Office suite, electronic document and information management systems, engineering software tools, and MS Excel spreadsheet creation and data analysis.

Nice To Haves

Experience using control system software.
Experience using MS Project.

Responsibilities

Direct engineering, validation, capital project, and maintenance activities for the site.
Oversee corrective and preventive maintenance and repair of facilities, utilities, and equipment.
Direct improvements intended to reduce equipment failures and errors.
Oversee capital projects and operational improvement projects, deviations, CAPAs, and change controls, ensuring they meet their objectives.
Represent Facilities & Engineering during client audits and regulatory inspections.
Ensure engineering, maintenance, and calibration procedures and systems remain compliant and controlled.
Establish and maintain metrics and reporting to evaluate facility and maintenance activities.
Direct, develop, and implement controls and systems for Plant Engineering, Facilities, Maintenance and Calibration, Validation, and CAPEX project functions.
Develop strategies, plans, and execution approaches to drive improvements and achieve objectives and goals.
Plan resources and manage performance, including coaching, mentoring, employee development, and discipline.
Manage employment-related matters for supervised employees, including motivation, counseling, discipline, and status changes.
Build teams and support organizational development and training.
Provide technical decisions on project implementation and change-control requirements, including drafting and owning risk assessments, plans, and procedures.
Review and approve team members’ work and engineering documents.
Coordinate with other site functions and work across functional boundaries in a matrixed organization.
Support monthly reporting on overall status, key issues, and performance KPIs.