Job details

QC Instrumentation Specialist

Overview:

The Instrumentation Specialist will ensure QC instrumentation is on-boarded, updated as necessary, and compliant with Data Integrity standards in accordance with company policies and procedures. This is a new role within the QC department at FujiFilm Diosynth Biotechnologies RTP to support the BIC expansion and Holly Springs project. The position will be responsible for cross-training with the validation team such that the principles and practices currently applied across the company can be executed within the Quality Control department’s scope. The position will also be expected to liaise with facilities, engineering, and IT to ensure the infrastructure is in place to support the validation and integration of new and existing instruments and software.

External US:

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Ensure the equipment and instrumentation needs across all disciplines of Quality Control are identified and transparent.
Author and implement project plans, change control, user requirements and standard operating procedures.
Develop and execute Installation Operational Qualification (IOQ) and performance qualification (PQ) protocol (if applicable).
Review all instrument qualification documents, provide constructive feedback, and ensure that the deliverables adhere to associate Standard Operating Procedures (SOP).
Complete periodic reviews of laboratory instruments and associated instrument control software.
The position will be expected to work cross functionally with the validation team onsite, employing the company policies as applicable for the validation.
The incumbent will be able to work cross functionally with End Users, Engineering, Labware Specialists, and the Quality Assurance team.
Lead Data integrity assessments and remediation serving as the subject matter experts.

BACKGROUND REQUIREMENTS:

BS/MS in relevant Science or Engineering discipline, chemistry, biochemistry, pharmaceutical sciences, or related technical field.

Desired Experience

3+ years of experience in a cGMP pharmaceutical environment. Preferably working with the validation or integration of complex instrumentation.

Specific Skills and Competencies

Hands on experience with analytical instrumentation associated with three or more of the following technologies: UPLC/HPLC (preferably using Waters Empower Software), capillary electrophoresis/imaged capillary isoelectric focusing (preferably using Waters Empower Software), gel electrophoresis/Western blot, plate-based assays, qPCR, spectrophotometry, and mass spectrometry.
Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point).
Ability to work with minimal supervision.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
Excellent verbal and written communication skills and attention to detail.
Thorough understanding of the pharmaceutical/biotech testing.
Proven ability to understand and implement data integrity standard and regulations
Previous experience with the validation of complex instrumentation in the Biotech / pharma environment.
Proven ability to conduct investigations, writing deviations and CAPA’s
Superior technical writing and problem-solving skills required.
Experience in Trackwise system preferred.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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3.7

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CEO of FUJIFILM

Teiichi Goto

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By FUJIFILM

FUJIFILM Holdings no longer dwells only on the negatives. Its Imaging Solutions unit makes color photographic films and papers, digital cameras, photofinishing equipment, and chemicals. It leads the film market in Japan and has hammered away at ri...

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FUNDING

Private

INDUSTRY

Electronics Manufacturing

TEAM SIZE

501-1000

LOCATION

Hybrid, based in Tokyo, Japan

DATE POSTED