Vice President, Facilities & Engineering

KBI Biopharma•Durham, NC

18d

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 and develops engineering, validation, maintenance, and capital project staff, ensuring equipment and systems are properly designed and installed and consistently perform as intended. The Vice President establishes strategies, processes, systems, procedures, and metrics to support facility and equipment availability, reliability, performance, safety, and quality, and monitors work orders, change controls, qualification status, and readiness. The role also manages engineering and facilities processes for new product introductions and develops and implements strategies and procedures for new and existing facilities and equipment. 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 the functional area to clients, auditors, and inspectors; oversees engineering support across multiple systems, processes, or areas; develops subject matter experts; and applies advanced approaches to implement strategies, technologies, and major improvements. Responsibilities include directing, reviewing, and approving engineering documents; supporting monthly reports on status, issues, and performance KPIs; and implementing controls and systems for Plant Engineering, Facilities, Maintenance and Calibration, Validation, and CAPEX project functions. The position provides technical decision-making on project implementation strategies and project and change-control requirements, including drafting and owning risk assessments, plans, and procedures and reviewing and approving team members’ work. It requires effective collaboration with quality, validation, maintenance, and other technical disciplines, strong internal and external customer service, and knowledge of quality systems and cGMP requirements across regulatory jurisdictions including FDA, EU, and ICH. The Vice President is also responsible for employee management, team building, organizational development, training, resource planning, performance management, coaching, mentoring, and staff development.

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.
Ability to use negotiation skills to drive critical issues to resolution.
Ability to summarize complex issues and present them to executive management.
Broad understanding of applicable codes and in-depth working knowledge of cGMP requirements and regulations.
Demonstrated quality and customer-service orientation, integrity, personal responsibility, communication across organizational levels, ability to align growth requirements with profit objectives, risk assessment and management, project management under aggressive timelines, and staff development and coaching.
Ability to read and interpret regulatory documents, industry technical papers, technical documents in English, schematic drawings, P&IDs, engineering specifications, safety rules, operating and maintenance instructions, procedure manuals, and batch and production records.
Ability to write technical and communication documents and concise reports, and communicate effectively with executive management, managers, technicians, government agencies, customers, internal groups, and external clients and inspectors.
Ability to solve practical problems independently with minimal supervision and deal with situations involving limited data.
Ability to apply engineering principles and interpret federal, state, and local code requirements.
Strong time-management and multitasking skills in a fast-paced environment.
Ability to produce consistent, high-quality documentation with attention to detail and SOP requirements.
Ability to grasp complex technical concepts and explain 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, compute rates, ratios, and percentages, and draw and interpret bar graphs.
Ability to lift and carry up to 25 pounds.
Computer skills with MS Office, electronic document/information management systems, engineering software tools, and MS Excel spreadsheet creation and data analysis functions.
Working knowledge of safety factors related to facility and utility support equipment, unit operations process equipment, process support equipment, temperature-mapping instrumentation, and computerized workstations.

Nice To Haves

Use of control system software.
Use of MS Project.

Responsibilities

Direct engineering, validation, capital project, and maintenance activities for the site.
Oversee corrective and preventative maintenance and repair of facilities, utilities, and equipment.
Direct implementation of improvements to reduce failures and errors.
Oversee capital projects, 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 effectiveness.
Manage employment matters for supervised employees, including motivation, counseling, discipline, and changes in status.
Lead team building, organizational development, and training.
Develop strategy, plans, and execution to drive improvements and achieve objectives and goals.
Manage resources and performance, including coaching, mentoring, development, and discipline.
Develop strategies, processes, systems, procedures, and metrics for facility and equipment availability, reliability, and performance.
Monitor equipment work orders, change controls, qualification status, and readiness.
Manage facility and engineering processes associated with new product introductions.
Coordinate with site functions and peers across a matrixed organization.
Direct, review, and approve engineering documents and support monthly reports on status, issues, and performance KPIs.
Develop and implement controls and systems for Plant Engineering, Facilities, Maintenance and Calibration, Validation, and CAPEX project functions.
Provide technical decisions on project implementation strategies and requirements for projects and change controls; draft and own risk assessments, plans, and procedures.
Review and approve team members’ work and provide customer service to internal and external clients.