With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Laboratory Systems Administrator is accountable for the management and administration of all IT-related functions pertaining to laboratory computerized systems and applications, including both standalone and enterprise platforms, within a GxP-compliant pharmaceutical laboratory environment. Responsibilities encompass system implementation, hardware and software configuration, troubleshooting, user account management, data backup and restoration, and ensuring the integrity of data generated by laboratory instrumentation and associated software. Furthermore, the Laboratory Systems Administrator provides comprehensive support for the operational continuity and compliance of laboratory computerized systems, ensuring seamless day-to-day functionality.
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Responsibilities- Direct and oversee projects for the procurement, integration, implementation, and upgrades of laboratory software, instrumentation, and computerized systems, ensuring alignment with Abzena and health authority regulatory, quality, and compliance standards.
- Manage validation and documentation activities, including the creation, review, and approval of Computer System Validation (CSV) documentation, change controls, and Good Manufacturing Practice (GMP) documents such as Standard Operating Procedures (SOPs).
- Establish, implement, and maintain data integrity policies and procedures to ensure compliance with regulatory requirements and laboratory quality standards.
- Serve as the primary point of contact for troubleshooting and resolution of issues related to laboratory computerized systems, ensuring uninterrupted operations and timely backup of electronic data.
- Collaborate effectively with laboratory management, business stakeholders, IT personnel, vendors, and technical teams to support system implementation, maintenance, and operational objectives.
- Develop and deliver training for laboratory and IT personnel, ensuring proper utilization of laboratory systems and adherence to compliance requirements.
- Support audit readiness initiatives and represent IT during internal and external audits, including inspections by regulatory bodies such as the FDA and customer audits.
- Identify and address deviations, implementing corrective and preventive actions to drive continuous improvement in laboratory quality, data integrity, and compliance.
Qualifications- 10+ years of experience in the pharmaceutical
- Knowledge of pharmaceutical analytical laboratory procedures and USP
- Experience working in the pharmaceutical industry and/or analytical laboratory
- Demonstrated experience with computer system validation and system lifecycle methodology is a must
- Experience and knowledge of the Empower Chromatography Data System.
- Experience and knowledge of LIMS and Electronic Laboratory Notebook is preferable.
- Knowledge of GMP, Industry Guidelines (ICH/FDA)
- Sound knowledge of 21CFR Part 11 compliance
- Highly organized individual with attention-to-detail
- Comply with all cGMP requirements and company policies, procedures, rules and regulations
- Must possess excellent verbal and written communication skills
- Strong analytical and problem-solving skills
- Demonstrates ability to prioritize conflicting demands
- Perform duties with minimum supervision
- Execute assigned tasks within established schedule
- Knowledgeable with MS Office applications (Word, Excel, Access, Outlook Excel)
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FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.