Job Description

The Senior Director 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 is responsible for developing and implementing strategies, methods, and procedures for new and existing facilities and equipment.

The Senior Director 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.

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

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.