Associate Director Engineering & Automation

Position Summary:

The Associate Director, Engineering & Automation is responsible for equipment and system performance of a cGMP biologic drug substance manufacturing facility. The Associate Director leads, manages, and coaches a team of engineers to manage equipment performance, troubleshoot problems, continuously improve, maintain compliance with current GMP and regulatory expectations, and mitigate risk.

The Associate Director oversees day to day equipment readiness and performance.  Monitors equipment change controls, qualification status, and readiness.  Manages processes associated with utility systems, process and building automation systems, HVAC, and process equipment. The Associate Director is responsible for managing and improving strategies, methods, and procedures to streamline existing operating procedures and new product introductions to the plant equipment. 

The Associate Director works to ensure alignment and coordinates with other functions such as Project Engineering, Validation, Maintenance, Manufacturing, MS&T, AFS, Process Development, and Quality Assurance.  Supports efforts of the organization across functional boundaries.  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.

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 will actively manage a team of full-time employees and contractors. This includes the following:

• 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

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.

Requirements:

Knowledge, Skills, Abilities

Minimum of Bachelor’s degree in an engineering, or biochemical engineering discipline and 8+ experience in the pharmaceutical/biotechnology field equivalent required 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 regulations including cGMPs.

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

Risk assessment and risk management

Project management including project delivery under aggressive timelines

Staff development and coaching

Additional Preferred Qualifications:

Project Management

Automation background

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 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.

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); Computerized work stations

Salary Range: $152,000 - $190,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.   

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.