Job Description Summary
Under the direction of the manager, this position works independently and serves as a technical subject matter expert for assigned applications including Laboratory Information Systems(s) for all Creative Testing Laboratories (CTS). This position is responsible for configuring, maintaining, troubleshooting, and/or updating the applications portfolio as well as maintaining any interfaces in the environment. Develops automated and non- automated testing scripts for application validations. Performs administration tasks for the assigned applications. As a senior member of the Applications team, this position helps guide application support, business process improvements, major application changes, knowledge sharing, and planning for future needs.
Job Description
PRIMARY DUTIES AND RESPONSIBILITIES
- Maintains required software configurations to meet evolving business and user needs.
- Leads and implements solutions that add value, are stable, and can be supported through the product lifecycle.
- Collaborates with both internal and external healthcare partners, the CTS Applications Manager, and enterprise architects to ensure business needs are understood and addressed.
- Serves as the senior resource for assigned applications, helping guide application support, business process improvements, and decisions about future enhancements and changes.
- Partners with vendors, business stakeholders, and IT teams to evaluate application changes and technical solutions, helping ensure they meet business needs and can be effectively supported by CTS.
- Leads and supports major application initiatives, including new implementations, upgrades, integrations, and other significant changes to business-critical systems.
- Partners with laboratory and business stakeholders to identify opportunities to improve processes, simplify support, standardize configurations where appropriate, and strengthen application support across CTS.
- Creates and maintains documentation that meets CTS software development lifecycle (SDLC), change control, quality, and validation requirements.
- Represents IT in assigned project discussions and helps keep application work moving by communicating clearly, raising concerns, and following decisions and action items through completion.
- Provides subject matter expertise for the applications supported by CTS IT, including internally developed and vendor provided applications.
- Troubleshoots complex production applications, interfaces, laboratory instruments, hardware, and software issues. Provides issue coordination through resolution.
- Develops, executes, and reviews test plans, including automated test cases when appropriate.
- Keeps application documentation and support procedures current. Cross-trains other team members to share critical knowledge and ensure continuity of support.
- Provides day-to-day technical guidance and mentoring to application analysts, administrators, and other team members without direct supervisory responsibility.
- Participates in disaster recovery planning, application recovery testing, contingency planning, and business continuity exercises for assigned applications.
- Builds shared knowledge and support capability across lab applications as CTS aligns laboratory application environments.
- Performs all duties in compliance with internal SOPs and applicable FDA, cGMP, and quality requirements. Brings compliance concerns to management.
- Provides quality service to CTS customers.
- Maintains good attendance and punctuality in accordance with the absence policy.
- Performs other duties as assigned by management.
REQUIRED QUALIFICATIONS
- Education: Bachelor's in a relevant field or equivalent combination of education and experience.
- Experience: A minimum of 8 years of related enterprise application experience, or an equivalent combination of education and progressively responsible experience.
- At least 2 years of experience with programming languages and SQL commands.
- Experience independently supporting, administering, improving, or implementing business-critical applications.
- Experience with server platforms and operating systems.
- Experience with computer system validation methods and procedures.
- Experience leading technical work, solving complex application problems, or coordinating work across business and IT teams.
- Experience documenting processes, sharing knowledge, mentoring others, and building backup support for critical responsibilities.
PREFERRED QUALIFICATIONS
- Experience supporting or administering Laboratory Information Systems.
- Experience supporting laboratory operations or another FDA-regulated environment.
- Experience with Automated validation tools.
- Experience providing support to a laboratory focus work environment.
- Knowledge of computer change processes and applicable FDA and cGMP requirements.
- Knowledge of standard disaster recovery and business continuity processes.
- Experience with application implementations, upgrades, integrations, migrations, or major system changes.