The Senior Systems Analyst collaborates with the business and IT teams to provide support for MA Biologics Operations Site Functions Quality, Manufacturing, and Product Development.
The Senior Systems Analyst manages their work with limited supervision and is the technical lead for complex, medium to large-scale IT systems and projects up to $1M.
The scope of work includes, but is not limited to the following:
- Maintain and execute project and operational support initiatives
- Oversee and participate in the architectural design, development, customization and integration efforts
- Provide oversight of vendor-provided solutions
- Handle ad-hoc technical requests from both internal and external partners
The Sr. Systems Analyst is a key member of the MA Biologics Operations IT team and is a focal point of customer engagement for initiatives as assigned by the IT Applications Manager.
10-20% Strategic Partnering:
- Work with stakeholders to understand requirements and provide operational oversight for the implementation of approved global solutions
- Keep abreast of technology trends in the market and evaluate for potential value to the company
30-50% Plan and Build:
- Establish and coordinate initiatives that are part of the IT portfolio
- Participate in Business meetings to understand business requirements
- Work closely with project teams (IT, Business, Validation, and QA) during planning and design phases to ensure appropriate solutions
- Consult during the selection of external service providers
- Evaluate proposed IT infrastructure changes to determine potential impacts to systems operations and compliance
- Function as a subject matter expert for applications
- Provide configuration solutions and advice and develop customizations, as required, within the context of technical standards
- Develop new features requested through requirements gathering from projects, pilots or tests and implement these features specifically or broadly, as the situation dictates
- Create SDLC documentation Function Requirement Specification (FRS), System Design and Configuration Specification (SDCS), System Admin SOP and Operation and Maintenance SOP (O&M)
- Assist with and contribute to application validation efforts, including installation qualification, operational and performance qualification
- Partner proactively with IT infrastructure Partners to ensure optimum operational performance of delivered solutions
- Provide IT support during FDA/Regulatory Authority Inspections and Readiness
Education and Experience Requirements
- More than 5 years relevant IT/business experience, including project scoping, analysis, and documentation of business and technical requirements (required)
- Experience with software application implementations in GxP environment (required)
- Bachelor's degree in information technology, computer science, engineering, or business administration (required)
- Experience in the Pharmaceuticals or Life Sciences industry (preferred)
- Experience consulting or working in a complex, global matrix organization (preferred)
- Knowledge of Lean operational techniques (preferred)
Key Skills, Abilities, and Competencies
- IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments Empower, Chromeleon, SOLO VPE, GE Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, GE DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX, PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and various Laboratory desktop applications used in GxP environment
- Familiarity with Automation systems such as SCADAs, PLCs, DCS, BAS, Historians
- Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 regulations, and Data Integrity compliance
- Experience working with ITIL processes in ServiceNow such as Incident Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
- Familiarity with following tools and processes
- TrackWise CAPA, Deviation, Change Control
- Veeva Document Workflows
- SABA Training Compliance
- Familiarity with Operational Excellence and/or Continuous Improvement processes
- Knowledge and familiarity of following Tools and technologies
- MS Office 365, MS Visio, MS Project
- Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore
- Architectures 2 Tier, 3 Tier, On-premise, Cloud
Other Job Requirements
Domestic travel; limited possible international travel.
- Must be able to lift, push, pull and carry up to 10 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.