Senior MFG & PLM Application Analyst

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simtra BioPharma Solutions:

As the Senior Manufacturing, Product Life Cycle, Serialization Application Analyst, you will play a critical role in enhancing the user experiences with cloud-based enterprise ERP related applications and ensuring for our organization. Your responsibilities will include a variety of duties related to the integration, administration, upgrade, testing and support of Manufacturing, Product Lifecycle Management and Serialization enterprise software applications. Your ability to translate the requirements of our internal customers into robust solutions will be essential in this role.

What you’ll do:

• Provides technical project leadership in the planning, design, development, testing, and implementation of application software.
• Conducts software application testing and other preparation for software upgrades or new software implementation

• Monitors, analyzes, plans, and assists end-users with the implementation of new software releases and upgrades.
• Research system enhancements and executes implementation.
• Conducts database analysis; researches and analyzes problems with applications and resolves or formulates solutions.
• Provides leadership in problem solving, which requires the consideration of the IT strategic plan and short-term goals, the means by which to solve the problem, and development of associated action plans.
• Work with vendors to ensure system operability/functionality and to ensure success of system implementations and upgrades.
• Reviews projects, analyzes business requirements, recommends system changes, writes specifications, and implements application changes to address changing application and end user requirements.

• Contributes to ongoing process to integrate end users requests with software functionality to address changing.
• Creates and maintains technical documentation and architecture diagrams as required.
• Analyzes and provides recommendations relating to application configuration and functionality of systems to ensure reliability for current and/or future use.
• Works directly with project managers to understand application objectives, develop scope of project, outline effort projections, determine schedules, and finalize plans.
• Establishes and enforces standards, policies and procedures for Manufacturing, Product Lifecycle Management & Serialization related application systems.

• Participate in the development and implementation of the information technology goals, objectives, policies, and priorities.
• Assist in assessing the strategic direction of information technology and in developing strategic plans for use of new technology.

What you’ll bring:

• Bachelor’s degree in Information Technology or Computer Science or equivalent experience in an Information Technology environment.

• Hands on experience configuring and implementing Microsoft Dynamics strongly preferred. Preferably within Production, Inventory, Product Information Management, Warehousing, and/or Master Planning modules

• Five years experience in Manufacturing discipline as an Information Technology Analyst or a related function performing
• User support
• Training
• Supporting installation, development, and maintenance of the business application software and servers, including the development of associated metadata and user interfaces
• PMP certification preferred
• Support large scale complex software application(s)
• Working knowledge of MS Dynamics Finance & Supply Chain application
• Experience in integrated SaaS enterprise solution network and infrastructure environment
• Demonstrates diagnostic skills and expertise to assist with problem determination and solution across the enterprise solution environment.
• Analyze software application problems and issues and drive to root cause solutions
• Create and meet deadlines
• Deal with multiple high priority issues simultaneously
• Develop and manage projects of significant scope with considerable impact on the organization
• Deal with controversial or sensitive issues
• Perform analysis at a high level
• Excellent written and oral communication skills

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Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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