- Job Level:
$90,000.00 - $100,000.00 plus Bonus
We are currently seeking a Systems Analyst – Manufacturing IT who will be responsible for the translation of business problems and requirements into an information system solution following an accepted project methodology. Within this responsibility falls the analysis of an information system's requirements, design specification, project life cycle planning, project implementation, support, and resource utilization. These activities must comply with the company’s validation guidelines to attain/maintain a regulatory compliant state.
The Systems Analyst – Manufacturing IT is responsible for communicating across various teams internal and external to IT. This individual is also responsible for maintaining compliance requirements and adhering to company’s SOPs, policies and assuring that all duties are performed in accordance with company’s principles and values.
- Assists the Senior Manager - Infrastructure and Operations, IT in the daily support of all production Manufacturing/Engineering/QA/QC systems.
- Recommends information system solutions of business problems leading to enhancement of existing systems, creation of new applications, or purchases of solutions from third parties.
- Responsible for the creation, throughput, and follow up of all SDLC documentation for related projects.
- Responsible for the creation, approval, and accurate execution of project installation, operational and performance qualification testing for related projects. This includes the generation, review and execution of change control procedures maintaining a regulatory compliant environment.
- Acts as liaison between Chelsea and Waltham location business groups and IT to translate business needs into IT action items.
- Represents the Senior Manager - Infrastructure and Operations, IT in his/her absence
- Performs other related assignments and duties as required and assigned.
- Bachelor’s Degree in a related technical field required
Experience & Skills Required
- Minimum of 3-5 years of experience with computer system implementation and support in a regulated Manufacturing environment required.
- GMP/GLP/FDA regulated environment experience is critical.
- Strong technical background in Relational Database Management Systems (RDBMS), Structured Query Language (SQL), ERP Systems, and application development required.
- Background in Manufacturing, Laboratory, Quality and/or Engineering Systems
- Experience with Validation procedures and proper GxP documentation practices
- Experienced working in a project team / project based environment
- Technical background in Oracle, SQL, and application development/deployment
- Working knowledge of SOPs, cGxP and project methodologies
- Must be proficient in MS Office Suite including Visio.
- Must be proficient in SQL and Manufacturing Execution Systems.
- Excellent written and verbal communication skills.
- Ability to multi-task, adjust priorities and work autonomously.
- Exhibits superior customer service skills.
- Demonstrates attention to detail.
- Ability to perform duties independently and in teams effectively in a highly dynamic fast-paced environment.
- A PMP certification is preferred.