Senior Director/Vice President, Facilities & Engineering

JOB SUMMARY

The Senior Director/Vice President, Facilities and Engineering is responsible for the building and equipment and system performance of a cGMP manufacturing facility. The Senior Director/Vice President leads, manages, and coaches engineering, validation, maintenance, and capital project staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. S/He develops an engaged, high performing team that demonstrates KBI core values with a culture of safety and quality.

The Senior Director/Vice President develops strategies, processes, systems, procedures, and metrics to achieve a high level of facility and equipment availability, reliability, and performance. S/He monitors equipment work orders, change controls, qualification status, and readiness. Manages facility and engineering processes associated with new product introductions. The Senior Director/Vice President is responsible for developing and implementing strategies, methods, and procedures for new and existing facilities and equipment.

The Senior Director/Vice President works to ensure alignment and coordinates with other site functions such as Finance, Manufacturing, MS&T, QC Analytical/Laboratories, and Quality Assurance. Leads efforts of the organization across functional boundaries and works with peers across a matrixed organization. Represents the functional area to clients, auditors, and inspectors.

Oversees engineering support for multiple systems, processes, or areas. Develops subject matter experts in several areas. Applies advanced approaches to develop and implement strategies, technologies, or other major improvements. Directs, reviews, and approves engineering documents. Support monthly reports covering overall status, key issues, and performance KPI’s.

Responsible for directing, developing, and implementing the necessary controls and systems for the Plant Engineering, Facilities, Maintenance and Calibration, Validation and CAPEX project functions.

Staff will provide technical decision-making regarding project implementation strategies as well as requirements for projects and change controls. This includes drafting and owning risk assessments, plans, and procedures. Staff will be responsible for reviewing and approving team member’s work.

Staff member will be expected to provide exceptional customer service to internal and external clients. Staff must have the ability to interface effectively with personnel across quality, validation, maintenance, and other technical disciplines. Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate and escalate risk is required.

JOB RESPONSIBILITIES

• Directs 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. Oversees multiple capital projects and operational improvement projects, DEVs, CAPAs, and/or Change Controls while ensuring their success in meeting their respective objectives.
• Represent the Facilities & Engineering activities during client audits and regulatory inspections.
• Ensures engineering, maintenance, and calibration procedures and systems are in a state of compliance and control. Establish and maintain a system of metrics and reporting to evaluate the effectiveness of facility and maintenance activities.
• Responsible for the employment, employee motivation, counseling, discipline, and changes in status of employees supervised. Responsible for team building, organizational development, training.
• Development, strategy, planning, and execution related to drive improvements and achievement of objectives and goals.
• Resource planning and performance management including coaching, mentoring, development, and discipline.

MINIMUM REQUIREMENTS

The requirements listed below are intended to show the base level minimum competencies/skills required to achieve each job level within the job function. These competencies/skills are only part of the evaluation process for advancement within the job function but server as a road map for potential advancement. Other factors in the evaluation process for advancement include things such as impact, leadership qualities, experience, education, business needs, etc. These factors are documented through the evaluation process and 1:1 with manager.

Knowledge, Skills, Abilities

• Minimum of Bachelor’s degree in an engineering discipline (mechanical, electrical, chemical, biomechanical). Minimum 15 years engineering experience with minimum of 10 years in biotech industry and 5 years management experience
• Established expertise and knowledge of 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 complex issues and present to executive management.
• A broad understanding of applicable codes, and in depth working knowledge of cGMP requirements and regulations.

Demonstrated track record in the following key areas:

• Strong orientation for quality and customer service
• High level of integrity and personal responsibility
• Communication skills within all levels of an organization
• Ability to align growth requirements and profit objectives
• Risk assessment and risk management
• Project management including project delivery under aggressive timelines
• Staff development and coaching
  

Language Ability

• Ability to read and interpret regulatory documents and industry technical papers, technical documents (in the English language), schematic drawings, P&IDs, engineering specifications, safety rules, operating and maintenance instructions, procedure manuals, batch and production records.
• Ability to write technical documents and communication documents. Ability to concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers.
• Ability to speak effectively before internal groups or employees of organization and external clients and inspectors.

Reasoning Ability

• Ability to independently solve practical problems with minimal supervision and deal with a variety of concrete variables in situations where limited data may exist.
• Ability to apply sound engineering principles and interpret federal, state and local code requirements.
• Strong time management skills and an ability to multitask in a face paced environment. Ability to deliver consistent high-quality documentation paying attention to detail and thoroughness relative to SOP requirements.
• Ability to quickly grasp complex technical concepts and make them understandable and corollary in text and graphics.
• 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.
• Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

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.
• Preferred: Use of control system software and 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); Temperature mapping instrumentation (data loggers), Computerized workstations.

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.