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.