The Systems Analyst – Manufacturing IT is 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.
_*_ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- 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.
- Potential multi shift support in a 24 x 7 Manufacturing environment.
EDUCATION AND/OR EXPERIENCE:
- Bachelor's Degree in a related technical field required
- Minimum of 3-5 years of experience with computer system implementation and support in a regulated Manufacturing environment required.
- Strong technical background in Relational Database Management Systems (RDBMS), Structured Query Language (SQL), ERP Systems, and application development required.
SUPERVISORY RESPONSIBILITIES: None
QUALIFICATIONS:
- Background in Manufacturing, Laboratory, Quality and/or Engineering Systems to include but not limited to:
- Inventory Management Systems (Great Plains)
- Barcode Labeling Systems
- Electronic Laboratory Notebook Systems (Biovia)
- Waters Laboratory Systems (Empower)
- Agilent Laboratory Systems (UV/Vis)
- Security Systems (Badge and Camera)
- Building Management Systems (Schneider BMS)
- SCADA (Rockwell)
- 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
COMPUTER SKILLS:
- Must be proficient in MS Office Suite, including Visio.
- Must be proficient in SQL and Manufacturing Execution Systems.
CERTIFICATES, LICENSES, REGISTRATIONS:
- A PMP certification is preferred.
OTHER SKILLS AND ABILITIES:
- 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.
PHYSICAL DEMANDS:
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Some weekends or holidays may be required. Position requires being accessible via company issued mobile device.
- Must be able to move hardware devices among communications and server racks (lift up to 20 lbs.).
- This position requires minimal travel; average travel for this position is 5% -10% with some variation based upon the demands of the business imperatives.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.