Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The role of IT Sr. Business Analyst is to oversees medium to large projects, or in some cases multiple small to medium projects, typically at the Division level. Project management responsibilities include the coordination and completion of projects on time within budget and within scope. Supervise all aspects of projects. Set deadlines, assign responsibilities and supervise and summarize progress of project. Prepare and present reports for senior management and steering committees regarding the status and health of the project(s). Brings together business requirements and to detail custom configuration needs. Reviews, analyzes, and modifies systems to system based on business needs for the PSG IT program for new and existing sites in the Thermo Fisher Pharma Services Group (PSG) division. Good interpersonal and multitasking skills will be required to lead business critical GMP business analyst activities in a global network.
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The successful candidate will coordinate technical installation of Manufacturing Operational Technology (OT) hardware and software solutions that support GxP compliant systems, including the following examples of OT devices Manufacturing Execution Systems, Computerized Maintenance Monitoring Systems, Sophisticated Analytic Systems, Serialization Systems, etc. . Collections, analyzes, and details technical requirements for business/IT system to ensure effective solutions delivery. This position will work with the Pharma 4.0 Sr Manager, and interact directly with the Thermo Fisher Corporate Pharma 4.0 IT group to provide GMP compliant system solutions. This role will be responsible for developing and maintaining standards that support GMP Manufacturing systems that are in alignment with GMP quality policies and procedures.
Responsibilities:
- Technical Support of manufacturing Pharma 4.0 IT systems :
- System support and documentation design
- Recommend and adapt solutions to business processes
- Testing of new features and functions
- Able to present solutions to senior management
- Act as business analyst for various manufacturing applications to include responding to tickets, assigned task work monitoring and critical issue alerts.
- Be able to perform hands on activities in addition to supervisory functions
- Assist in providing mentorship and requirements for additional services and support
- Proactive in asking questions and delivering preliminary ideas or draft work in order to get feedback
- Coordinate integration of manufacturing IT systems into the overall PSG manufacturing IT landscape including:
- Remediation of identified infrastructure gaps that pose security, data, or business continuity risk
- Adoption of MERA standards into M&A activities related to shop floor systems
- Work with peer Tech Leads and leadership in Corporate Infrastructure & Security (CIS) to implement technical solutions that are GMP compliant and meet Thermo Fisher Standards including:
- Fault-tolerant high availability datacenter solutions
- Detailed monitoring, backup solutions, network hardening, etc. specific to a regulated segmented network environment. Tech Lead compliant solutions unique to GxP segmented environments that are aligned to CIS guidelines
- Lead technical teams and third-party partners to implement Infrastructure upgrades to include Network, server, and storage compliant datacenter solutions to support direct impact production equipment
Business Analyst top skills & proficiencies:
- Convert functional requirements to technical specifications
- Possess a strong fundamental understanding of sophisticated IT systems, environments, equipment needs, and processes
- Good interpersonal and communications skills
- Strong presentation skills with tried experience delivering formal presentations to various levels of management
- Self-motivated and daring problem solver who can translate circumstances and understanding into actions that move the business forward; ability to work independently without significant direction
- Excellent critical thinking, fix, crisis management, and decision-making skills, perform under stress and tight deadlines in a sophisticated, matrixed environment
- Meticulous attention to detail and a passion for driving execution at a detailed level, while still maintaining the big picture
- Excellent oral and written communication skills
- Identifies and supports process improvement initiatives to support global teams for streamlining procedures
Requirements:
- BS degree in Information Technology, Computer Science or relevant field. Technical degree in business, computer science, engineering or related field or 7+ years related experience.
- Expertise with delivery and implementation of large, enterprise-wide projects. Preferably experience with Rockwell Automation's PharmaSuite, IBM's Maximo, Serialization Solutions (EdgeTrack, CodeSoft, TraceLink, Optel), Biologics Sophisticated Analytics (Discoverant), or equivalent.
- 7 years enterprise system and network administration experience in supervised environments preferred.
- Global cross-cultural experience preferred.
- Experience working remotely or in office setting, proactive and self-motivated.
- Experience with MS Office products and tools (Visio, word, excel, power point)
- Experience or ability to learn working in a validated environment and excellent knowledge of GMP Practices
- Customer oriented and able to communicate fluently in English.
- Demonstrate strong understanding of the manufacturing, engineering, quality and operational business areas related to the delivery of biotech products
- Software Development Life Cycle (SDLC) Management implementation
- GxP validated systems experience a plus. Regulatory, IT Compliance, Change Management knowledge