Job Information
Alkermes, Inc. Sr Systems Analyst, Information Systems Engineering-Manufacturing Systems - 13846 in Wilmington, Ohio
The Senior Systems Analyst role will drive the design, deployment, and support of manufacturing computer systems and integrated equipment at the Alkermes Wilmington facility. The successful candidate will build strategic business partnerships, drive business value, and foster a culture of innovation and compliance.
Responsibilities
Oversee and support the implementation and lifecycle management of vendor integrated & skidded equipment and other manufacturing computer systems.
Design, deploy, and maintain computer systems and supporting infrastructure to meet manufacturing, compliance, and reliability requirements.
Serve as a subject matter expert for assigned technical systems.
Partner with cross-functional teams including Operations, Engineering, Validation, Quality and Facilities to ensure system accuracy, data integrity, business continuity, and alignment with operational needs.
Troubleshoot and resolve complex hardware, software, and system-component issues, ensuring high availability of manufacturing systems.
Develop and manage vendor relationships, coordinating configurations, upgrades, incident management, and long-term support strategies.
Review new equipment and engineering projects for alignment with IT standards, coordinating with Infrastructure, Security, and Manufacturing to ensure compliant solutions.
Lead or contribute to system documentation, validation activities, SOP creation, and quality system records such as Change Controls and CAPAs.
Drive continuous improvement of IT processes, standards, and support services to streamline operations for Manufacturing.
Proactively identify opportunities and risks, anticipating customer needs and recommending value-added technical solutions.
Qualifications
Minimum Education & Experience Requirements:
- Bachelor's Degree in Information Systems, Engineering, Computer Science, or a related field.
- Minimum of 5 years of professional experience in Manufacturing, Information Technology or Automation Systems.
- Experience in the pharmaceutical or biotech industry strongly preferred.
Knowledge/Skills Needed:
- Knowledge of manufacturing computer systems and integrated equipment.
- Understanding of GMP/GxP compliance and system validation practices.
- Strong communication and documentation skills.
- Ability to design or support computer system architecture in a manufacturing setting.
- Willingness to learn software from various vendors, especially Rockwell Automation.
- Skilled in troubleshooting hardware, software, and system issues.
- Experience working with external vendors and supporting vendor-managed systems.
- Ability to create and maintain SOPs and technical documentation.
Competencies:
Technical Expertise
- Acts as a subject matter expert for all assigned technical areas
- Analyzes impact of new technology and makes recommendations
- Facilitates knowledge sharing and creative problem solving in/out of area of responsibility
- Has advanced skills in project management and continuous/process improvement
- Knows and/or has experience with pharmaceutical concepts (e.g. GxP, validation)
Collaboration and Communication
- Builds strong relationships with stakeholders external to IT and utilizes them to identify new opportunities
- Communicates well in team settings and understands diverse perspectives
- Mentors and motivates junior members of the team
Self-Awareness and Adaptability
Proactively manages changes and facilitates knowledge
sharing within areas of responsibility
Provides clar