About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The qualified individual will utilize knowledge of informatics to support R&D laboratories through development, support, and validation of computer systems. A foundation in the software development lifecycle is needed and a strong knowledge of computer programming languages, such as LabWare LIMS Basic, C++, Java, .NET, SAS, PHP, ColdFusion, SQL, and/or other web scripting languages, with LIMS development being the greatest focus. The individual will drive activities around computer programming, system administration, and support of computer systems used within clinical testing operations and will mentor other junior team members. The main activities, which include software validation, will focus on collecting business requirements, converting them to functional solutions, validating the solutions, and deploying them into a production environment.
The individual will have strong communication skills, have the ability to take direction and work independently, meet tight deadlines, coordinate activities across groups, train end-users, and assist with improving large scale processes. Not only will the individual be expected to contribute to technical tasks, but he/she will be expected to lead select projects independently.
Most of the activities performed follow GxP regulations, so an understanding of Quality processes and their relation to software administration, documentation, and programming is necessary. The individual will have a strong passion for innovation and all the activities that are associated, especially in adding efficiencies to subroutines and performance of algorithms. Some projects may require collaboration with statisticians to develop robust algorithms that analyze data.
• Use computer science/information systems/life sciences knowledge in order to design, build, configure, program, and/or validate computer code, master data, reports, forms, and interfaces.
• Write/update departmental SOPs, maintain technical paperwork, and migrate such data to archive repository.
• For select projects, lead the process of analyzing user requirements, models, and specifications in order to convert them to technical solutions.
• Lead activities around debugging and testing of any solutions.
• Lead some higher level validation activities, specifically around development of test scripts and other GxP documentation generated during system support and validation.
• Independently drive change management processes for routine changes, for example routine change controls.
• Provide day-to-day end-user support and take a leadership role in monitoring "help desk" support queue.
• Write and execute ad-hoc SQL queries.
• Satisfactorily complete all cGMP/GLP and safety training in conformance with departmental requirements.
• Interface regularly with internal business units/customers and CRO customers.
• Ensure network firewall connection is maintained and CRO partners maintain access.
• BS/BA in Computer Science, Information Systems, Life Sciences, or a related Computational Field with 9-12 years of experience or MS/MA in similar backgrounds, with 5-7 years of experience.
• Software certifications in IT related courses, specific experience/certificates in LabWare LIMS Basic, or an understanding of web development technologies (for example SharePoint and/or scripting languages), required.
• Strong knowledge of various programming languages, computer architecture, and/or algorithms, required.
• Experience with designing, developing, and querying databases, required.
• Knowledge of the software validation lifecycle, required.
• Knowledge of change control processes, required.
• Strong understanding of Excel and/or Access (and other database software), required.
• Experience in analytics and/or data collection/processing through statistical software, required.
• Certifications in Quality/business related topics, suggested.
• Experience performing biological assays, a plus.
• Excellent written and verbal communication skills, required.
• Proven track record of managing deadlines and scheduling workload, required.
• Experience indirectly managing others, preferred.
Work primarily performed at individual's desk or may require walking around to various laboratories/biosuites. Will spend a great deal of time coding, analyzing data, and testing technical solutions.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Weekend/night work required when coordinating off hour system upgrades or weekend end-user support. Travel may be required to vendors or collaborative sites, as needed.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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