KBI Biopharma

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Summary:

The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations.

Facilities Engineering oversees the architectural features of the buildings, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, and Automation for the facility.

A Senior Automation Engineer is responsible for providing technical support for ongoing operations by serving as a system owner for Facilities automation systems, maintaining the site in a compliant state, and ensuring engineering and quality standards are maintained. Facilities Engineering is responsible for the generation and implementation of Change Controls, Corrective Actions Preventive Actions, Deviations, and other quality system records.

As a part of project execution, a Senior Automation Engineer will support the design, implementation, commissioning, and validation of new systems or the modification of existing systems and serve as a project manager or lead project engineer for multiple concurrent projects. For larger, more complex projects, a Senior Automation Engineer will manage KBI engineering resources by assigning tasks, setting work priorities, and being responsible for project completion. A Senior Engineer will also manage outside contractors and trades.

Project Management activities may include scope definition, scope adherence, stakeholder agreement, budgeting, scheduling, risk management, procurement, and installation support.

Responsibilities:

• Direct or support concurrent automation engineering projects on both technical and project management aspects for capital and operational projects while ensuring their success in meeting their respective objectives.
• Support the maintenance oversight of site instrumentation, plant level automation hard and software, and oversight of the Manufacturing Execution Systems, Building Management System, and Data Historian.
• Support Validation with the planning and execution of commissioning and validation protocols.
• Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
• Develop and maintain standard operating procedures and other procedures for installed systems.
• Support and comply with engineering standards, drawing controls, project controls and other procedures and standards necessary for the successful operation of the department as well as the creation and maintenance of the same.
• Other assigned duties.

Requirements:

• Bachelor of Science degree in an engineering discipline and a minimum of 8 years of progressively responsible instrumentation/automation development, implementation, and maintenance activities or; Bachelor of Science degree and a minimum of 12 years of progressively responsible instrumentation/automation development, implementation, and maintenance activities.
• Minimum 5 years hands on experience with instrumentation and controls equipment including PLCs, HMIs, SCADA systems, and networking equipment
• Have strong automation engineering skills and ability.
• Have Fieldbus configuration and management experience with Profibus being preferred or be able to obtain the same.
• Experience with Unicorn, Wonderware, Rockwell Automation FactoryTalk, Rockwell Automation RSLogix, Siemens Apogee, Open Process Control (OPC) preferable.
• Experience with qualifiable MES systems, such as OSI Pi preferable.
• Must have experience with Windows Servers hardware and Microsoft Windows - applications.
• Experience with communication protocols including but not limited to RS-485, RS-232, Ethernet, Modbus & Profibus is preferable.
• Experience in Biopharmaceutical manufacturing preferable
• Must have experience with writing protocols, test scripts, user requirements, and system design documents.
• Must have strong organization, interpersonal, oral and written communication skills.
• Must be able to prioritize multiple commitments and technical problems.
• Must have the ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.

Language Ability:

Ability to concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers.

Reasoning Ability:

Ability to apply engineering principles and problem-solving skills to everyday challenges.

Math Ability:

Strong math and analytical skills required. Ability to perform heat load calculations and size utility systems. Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.

Physical Demands:

Execution of assigned tasks will require the ability to access hard to reach areas of the facility to include confined spaces, cramped or low ceilings, interstitials, and mechanical rooms.

Computer Skills:

Microsoft Office (Word, Excel, PowerPoint, and Project), AutoCAD

Equipment Use:

Standard hand tools, power tools, electrical multimeter, large format plotter, computer, telephone, copy and fax machines

WORKING CONDITIONS:

• Incumbents may work with toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment.
• Supports the 1101 Hamlin Road and 4117 Emperor Blvd North Carolina sites and may need to travel between sites during the workday.
• Non-routine off-hours weekday work may be required. Off-hours response time to system anomaly: 1 hour maximum.
• Non-routine week-end work may be required.
• Must comply with all applicable rules and regulations of the company and the Pharmaceutical / Biotech industry including FDA regulations such as cGMP, GDP, Health Safety Environment regulations and company regulations such as the employee handbook.

Salary Range: $116,000 - $162,800

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, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.