What are the responsibilities and job description for the Software Systems Lead position at American Injectables?
About Us
American Injectables is a fast-growing pharmaceutical CDMO, focused on enhancing our operations through the implementation and management of enterprise and manufacturing software systems. As we scale, we continue to invest and build upon our digital infrastructure, including ERP, asset management, LIMS, SCADA, and other critical systems to support our GMP operations.
To ensure the success of these systems, we are seeking a Software Systems Specialist to lead, implement, and oversee our facility's software ecosystem. This is a broad and strategic role, ensuring all enterprise and manufacturing software is properly implemented, optimized, and maintained over time.
Job Summary
The Software Systems Specialist will be responsible for the implementation, ownership, and optimization of all software systems used in our facility, including but not limited to:
- ERP systems (with pharmaceutical/life sciences modules)
- Asset management software
- LIMS (Laboratory Information Management System)
- Badge access/security systems
- SCADA, MES, and other industrial control software
- Quality management and document control systems
This person will act as both the implementation lead and the primary technical user for these systems. While not a software developer, they will have strong technical aptitude, an ability to quickly understand software architecture and functionality, and serve as a train-the-trainer expert for end users.
The role requires experience with multiple software implementations, a deep understanding of enterprise and manufacturing software in a regulated environment, and the ability to coordinate cross-functional teams including CSV (Computer System Validation), automation, IT, and operations.
Key Responsibilities
Software Implementation & System Ownership
- Contribute to the implementation and long-term ownership and strategy of all major software systems in the facility.
- Direct the rollout, configuration, and integration of enterprise systems like ERP, asset management, LIMS, and security systems.
- Serve as the primary point of contact and orchestrator for these software platforms.
- Manage vendor relationships, ensuring software providers deliver effective support and system improvements.
- Develop and enforce best practices, SOPs, and governance policies for software usage across departments.
System Optimization & Continuous Improvement
- Regularly assess system performance, user adoption, and opportunities for improvement.
- Work with internal stakeholders to enhance software functionality, add new features, and streamline workflows.
- Ensure seamless integrations between enterprise, manufacturing, and quality systems.
GMP Compliance & CSV (Computer System Validation) Support
- Collaborate with CSV teams to ensure compliance with GMP, 21 CFR Part 11, and data integrity requirements.
- Support IQ, OQ, PQ validation efforts for all GMP-relevant software.
- Maintain audit-ready documentation for system changes, upgrades, and validation.
Technical User & Training Lead
- Quickly develop deep technical expertise in each software platform, with minimal training.
- Serve as the train-the-trainer expert, providing user training, documentation, and troubleshooting support.
- Develop standard operating procedures (SOPs), user manuals, and best practices for software users across the organization.
Cross-Functional Collaboration
- Act as the bridge between IT, automation, manufacturing, and quality to align software solutions with business needs.
- Work with automation engineers to ensure SCADA, MES, and control software integrate properly with facility systems.
- Support the quality team in managing feature roadmaps, document control, CAPA, and deviation tracking software.
- Assist security teams with badge access and facility management software.
Qualifications & Skills
Must-Have:
- 5 years of experience implementing and managing enterprise and manufacturing software systems in a regulated industry.
- Experience with multiple software platforms, including ERP, asset management, LIMS, quality management, automation software, or others.
- Ability to quickly understand and master new software platforms with minimal training.
- Strong experience in software project management, vendor coordination, and system rollout strategies.
- Familiarity with GMP, 21 CFR Part 11, and validation requirements for software systems.
- Strong technical user aptitude, with the ability to assess software functionality, workflows, and integrations.
- Experience creating user guides, SOPs, and conducting end-user training.
Preferred:
- Pharmaceutical, biotech, or life sciences industry experience.
- Hands-on experience implementing over overseeing ERP systems for life sciences (SAP, Oracle, NetSuite, Microsoft Dynamics).
- Experience with LIMS and asset management systems.
- Understanding of CSV (Computer System Validation) protocols and risk-based validation approaches.
- Knowledge of MES, SCADA, and industrial automation software.
- Exposure to IT infrastructure management.
Why Join Us?
- Be an integral member for the implementation of critical enterprise and manufacturing software in a fast-growing CDMO.
- Work on a broad and diverse range of software systems, ensuring full digital transformation of the facility.
- Play a pivotal role in GMP compliance, system validation, and operational efficiency.
- Collaborate with cross-functional teams, working at the intersection of automation, IT, quality, and operations.
- Competitive salary, benefits, and opportunities for career growth and leadership roles.
