United States onlyThe role of the Manufacturing IT Sr. Systems Analyst is to capture business requirements and to document custom configuration needs. Reviews, analyzes, and modifies systems to system based on business needs for the PSG Manufacturing Pharma 4.0 IT program for new and existing sites in the Pharma Services Group (PSG) division. Strong organizational and multitasking skills will be required to manage multiple business critical GMP system analyst activities in a global network.
The successful candidate will oversee technical installation of Manufacturing Operational Technology (OT) hardware and software solutions that support Pharma Services Group (PSG) GxP compliant systems, including the following examples of OT devices Manufacturing Execution Systems, Computerized Maintenance Monitoring Systems, Advanced Analytic Systems, Serialization Systems, etc. . Gathers, analyzes, and documents technical requirements for business/IT system to ensure effective solutions delivery. 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
- Provide technical support for manufacturing Pharma 4.0 IT systems within the overall PSG manufacturing IT landscape
- Design and document system support and documentation
- Suggest and adapt solutions to align with business processes
- Test new features and functions
- Present solutions to the senior management
- Act as a system analyst for various manufacturing applications, including ticket response, task assignment, monitoring, and escalation alerts
- Perform hands-on activities as well as supervisory functions
- Collaborate with the global IT team to provide additional support
- Assist in providing guidance and requirements for additional services and support
- Proactively ask questions and deliver preliminary ideas or draft work to receive feedback
- Coordinate the integration of manufacturing Pharma 4.0 IT systems into the overall PSG manufacturing IT landscape
- Address identified infrastructure gaps that pose security, data, or business continuity risks
- Adopt MERA standards in M&A activities related to shop floor systems
- Interface with peer Tech Leads and leadership in Corporate Infrastructure & Security (CIS) to implement GMP-compliant technical solutions that meet standards
- Implement fault-tolerant high availability datacenter solutions for new and existing sites
- Implement specialized monitoring, backup solutions, network hardening, etc. specific to a regulated segmented network environment
- Implement Tech Lead compliant solutions unique to GxP segmented environments aligned with CIS guidelines
- Lead technical teams and third-party partners in implementing Infrastructure upgrades, including network, server, and storage compliant datacenter solutions to support production equipment directly
Requirements
- A bachelor's degree in information technology, Computer Science, or a relevant field, or a technical degree in business, computer science, engineering, or a related field, or at least 7 years of related experience
- Expertise in delivering and implementing large, enterprise-wide projects, such as Manufacturing Execution Systems, Computerized Maintenance Monitoring Systems, Advanced Analytic Systems, Serialization Systems, etc. Preferably, experience with Rockwell Automation’s PharmaSuite, IBM’s Maximo, Serialization Solutions (EdgeTrack, CodeSoft, TraceLink, Optel), Biologics Advanced Analytics (Discoverant), or equivalent
- Experience working in a matrix and shared services environment
- 7 years of enterprise system and network administration experience in regulated environments is preferred
- Global cross-cultural experience is preferred
- Experience working remotely or in an office setting, being proactive and self-motivated
- Experience with MS Office products and tools (Visio, Word, Excel, PowerPoint)
- Experience or the ability to learn working in a validated environment and excellent knowledge of GMP practices
- Customer-oriented and able to communicate fluently in English
- Demonstrating a strong understanding of the manufacturing, engineering, quality, and operational business areas related to the delivery of biotech products
- Experience in Software Development Life Cycle (SDLC) Management implementation is a plus
- Experience with GxP validated systems is a plus, including knowledge of regulatory compliance and change management
Additional Skills
- Ability to translate functional requirements into technical specifications
- Capability to work independently in a complex, matrixed environment and take ownership of the Tech refresh program
- Demonstrated ability to guide and lead others
- Strong understanding of complex IT systems, environments, equipment needs, and processes
- Excellent interpersonal and communication skills, both internally and externally
- Proven experience delivering formal presentations to management at various levels
- Self-motivated and independent thinker with the ability to take action without significant direction
- Excellent critical thinking, troubleshooting, crisis management, and decision-making skills
- Meticulous attention to detail with a focus on driving execution at a detailed level while keeping sight of the big picture
- Strong oral and written communication skills
- Identification and support of process improvement initiatives to streamline procedures for global teams
Benefits
A comprehensive benefits package which includes medical, dental, vision, disability and life insurance, 401k and a generous PTO Policy.
About Endeavor:
At Endeavor Consulting Group, our mission is to provide straightforward solutions to complicated situations. As a specialty project management technology and integration firm, we are laser focused on Operational Systems, Supply Chain Integration, and Product Development for Life Sciences enterprises. Our team is driven, energetic, and passionate about delivering results and earning the trust of our ever-expanding client base.
We are dedicated to building a thriving company culture and a workplace environment that fosters respect, honesty, and creativity. Our goal is to help our clients triumph; to do that, we must remain fiercely committed to ensuring the happiness and fulfillment of our employees. In pursuit of excellence, we look for individuals with a customer-focused approach to problem-solving, a desire to exceed expectations, a philanthropic point of view, a dedication to quality service, and a strong technological background.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We are committed to providing accommodation for employees with disabilities.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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