Laboratory Informatics Engineer

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POST DATE 9/8/2016
END DATE 10/26/2016

Mylan Inc Morgantown, WV

Mylan Inc
Morgantown, WV
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the worlds 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing whats right, not whats easy. If you are a doer and have a passion for serving others, we want to talk to you.

At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Heres how this role will help:

* Collect business process information from internal customers and application experience that lead to new Requirement Specifications. Prepare prototypes based on based on documented but potentially incomplete or ambiguous requirements employing software code, report design and/or configuration elements. Peer review prototype elements based on team best practices and requirements.

* Assist our Run organization providing operational information for our application software systems, troubleshooting software code and/or configuration elements and reports. Perform application maintenance, monitoring. Provide user community with ad-hoc data e.g. lab metrics, sample and lot reports.

* Author moderately complex validation tests and execute automated and manual scripts for IQ, OQ and PQ testing using HP Quality Center. Document and resolve defects detected during test execution. Prepare and debug installation procedures.

* Resolve incidents and changes arising from build initiatives through the ITIL based corporate management system. Present moderately complex changes at Change Advisory Board (CAB) meetings. Meet our SLAs and incident and change resolution target dates.

* Understand and comply with all established corporate, IT, and software engineering policies and procedures. Develop work instruction guidelines for administrative functions. Author system reference guides and other adjunctive materials to assist the user community in getting the greatest benefit from our systems. Comply with corporate financial control policies and procedures including procurement and capital time entry. Cross-train more junior team members in providing outstanding support services within the Laboratory Informatics Center of Excellence. Ensure all configuration is multi-language support ready.

* Stay abreast of new functionality offered by LabWare LIMS, Empower CDS, ELN, SDMS and other laboratory informatics solutions to advocate for the potential benefit of enhancements as they become available. Understand integration points with SAP and other strategic systems to fully grasp impact of all proposed system changes. Follow / contribute to the online community of system administrators. Maintain any relevant memberships and certifications where applicable.

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

* A minimum of a Bachelors degree in Chemistry, Computer Science or related scientific discipline, plus 5 years of experience in the pharmaceutical or a related industry, or MS/MBA Degree with 3 years of relevant experience. Candidates holding a Ph.D. without industry experience will be considered. A combination of experience and/or education will be taken into consideration.

* Must possess the ability to develop technical solutions to complex business process automation problems which require the regular use of novel solutions and approaches and team toolsets.

* A technical specialty in at least one of the following:

* LabWare LIMS =V6 with a focus on Raw Material Testing and/or Finished Product / Stability Testing and/or Environmental Monitoring.

* Waters Empower Chromatography Data System =V2.

* Electronic Laboratory Notebook (LabWare ELN or Accelrys SmartLab).

* Scientific Data Management System (Waters Vision Publisher).

* Laboratory testing experience in facilities manufacturing at least one of the following dosage forms: solid dose, dry inhalation powder, transdermal or sterile. Client/server database application development with Structured Query Language (SQL), DBMS (ideally Oracle =V 11g or MS SQL Server =2008). Deployment using Citrix, MS Windows platforms including MS server OS. Intermediate competency in MS Office tools, Excel and Access. HP Quality Center including LoadRunner and QuickTest Pro. MS Office Visio, Project, SharePoint experience.

* LIMS BASIC, SAP Crystal Reports, LabWare Pharma Kit v3, Structured Query Language (SQL), VMware Virtualization. Electronic Laboratory Notebook: Experiment Template Design & Method Automation. Required LabWare Systems Administration Certification (ideally with LabWare LIMS V6) or Waters Empower System Administrator or ELN certification (ideally LabWare ELN or Accelrys SmartLab). Certification in more than one discipline is a plus.

* Require an intermediate level knowledge of general networking and computing architectures, software development lifecycle, application lifecycle management, and database application system design. Must also possess knowledge of cGMPs, Pharmaceutical compendia, 21 CFR Part 11 validation and change control concepts and the ability to effectively apply those concepts to daily activities, system development, and system maintenance in the context of Pharmaceutical manufacturing and testing.

* Proficiency in speaking, comprehending, reading and writing English are required.

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 30,000 worldwide, we can make a difference. We encourage you to visit to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.

Job Posting: Sep 7, 2016, 8:08:06 AM
Unposting Date: Ongoing.