Senior Specialist, Quality Engineering

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:

This individual supports all QA activities related to Engineering, Validation and IT in a contract development and manufacturing organization (CDMO) setting. Responsibilities include the review and approval of: Change Control records and their deliverables and other GMP controlled documents, resulting in timely QA oversight of equipment, computer system, utility, and facility lifecycle activities including qualification/validation. This individual provides quality oversight of facility, utilities, equipment, and IT infrastructure upgrades and expansions, develops and supports continuous improvement initiatives, and supports client and regulatory audits, as required.

Responsibilities:

• Provide quality oversight of Engineering, Validation, and IT activities supporting both clinical and commercial operations (including plant shutdowns) in a CDMO setting.

• Support administration of the Change Control system through QA review and approval of change controls and identifying related continuous improvement opportunities.

• Work directly with Validation and Facilities Engineering to review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program. Track and report review and approval metrics.

• Provides general QA support as Quality Engineering for Facilities/Engineering (incl. Calibration), Validation, CSV, AFS, QC & Microbiology, Manufacturing, MS&T, Supply Chain, and IT departments - which includes review and approval of Deviation Investigations, CAPAs, procedures, etc. as required.

• In conjunction with Validation functional areas, develops and manages all validation policies, procedures, and protocols. Works to continuously improve and streamline the validation processes.

• Provides QA support by representing Quality Engineering in project core team meetings. Provide training to QA and other functional teams as required.

Requirements: 

• Senior Specialist: BS and 8+ years’ experience or MS and 6+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

• Principal Specialist: BS and 10+ years’ experience or MS and 8+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent. 

Salary Range: $101,000 - $138,600

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.