LIMS Data Integrity & Production Systems Manager
5800 Park of Commerce BLVD NW Palm Beach, FL 33410 US
National Biopharmaceutical company seeks a LIMS Integrity & Production Systems Manager for a growing organization just south of West Palm beach, Florida. This individual must reside locally and be willing to go onsite; relocation assistance is available. The ideal candidate will be responsible for maintaining cGMP software and IT systems within the laboratory and manufacturing areas, while managing system administrators within the Data Integrity Department. Additionally, this person will possess a deep understanding of the LIMS, ideally LabVantage v8 pharma overlay, and IT Data Integrity principles, prior expertise in various Lab IT Systems and full SDLC of IT Applications are required. Organization offers an extremely collaborative culture with a strong focus on cross-training to supplement knowledge transfer for all roles. Competitive compensation, benefits and growth are offered within this opportunity
- Competitive salary commensurate with experience.
- 401K of up to 4% with organization immediately vesting at 100%.
- Generous 12 Days PTO with 3 floating holidays; 8 observed holidays.
- Full Health, Vision, and Dental Insurance Benefits.
- Relocation assistance available based upon the individual situation.
- Maintaining cGMP IT and software processes within laboratory and manufacturing.
- Managing 2 system administrators within the data integrity department and serving as key leader in adding additional headcount.
- Serving as product owner of LabVantage LIMS v8 application.
- Maintaining all IT systems within the organization that require GMP oversite.
- Ensuring utilization and maintenance of Data Integrity and Compliance Best Practices within IT systems.
- Coordinating with cross functional teams to develop applications to meet end user requirements.
- Working with outside vendors on the development of product needs to ensure seamless utilization and functionality.
- Working with end users to gather business requirements and provide written solutions for further system utilization.
- Coordinating with validation teams to provide validated solutions accordingly within GMP regulations.
- Providing extensive system improvements and knowledge for LabVantage 8, pharma overlay in addition to other third-party systems and LIMS modules to include Batch Management, Sample and Environmental Monitoring, Stability, AQC, LES, SDMS, Empower, Software Max Pro and common lab instruments including pH Meters and Balances.
- Assisting in the Data Integrity leadership of upcoming projects to include Instrument Integrations using SDMS and Empower.
- Bachelors in computer science or related area.
- LIMS LabVantage v8 or higher, full SDLC implementations within a cGMP environment.
- Strong understanding of IT Data Integrity Principles
- Experience with various laboratory IT systems and the end user utilization of SoftMax Pro, Empower, UV-Vis, LabX, and common lab instruments like pH meters and balances.
- Prior expertise having supervised others, ensuring efficient prioritization of tasks to meet organizational goals.
- Knowledge of LabVantage Batch Management, Sample Monitoring/EM, Stability, AQC, LES, SDMS, Empower
- Basic knowledge of SQL is a plus.
- Conceptual understanding of Java and Groovy Programming.