The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
Our client is seeking a Benchtop Support Specialist in Libertyville , IL.
• Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing buildings.
• Support administration of quality and laboratory applications including their software development life cycle activities and technical support.
• Provide ownership of assets and utilize systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
• Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
• Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
• Lead or provide supporting activities within the quality management system (Infinity)
• Liaison with global partners within the organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training.
• Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration.
• Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
• Ensure alignment with directives and industry guidelines for applications.
• Execute on technology improvements and efficiency opportunities to improve business and compliance.
• Provide on-call support, as needed, for commercial operations.
Skills & Requirements
• Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
• Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
• Demonstrated leadership skills and the ability to negotiate in a complex environment.
• Excellent verbal and written communication skills.
• The ability to plan and lead small and medium size projects and enhancements.
• The candidate needs to be self-driven and capable of prioritizing.
• The candidate should have an expanding understanding of network, databases, servers, and PCs.
• Understanding of administration and usage of TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
• Ability to apply lean and OpEx principles.
• The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management. Education and Experience:
• Bachelor's degree in life sciences, engineering or computer field or equivalent experience.
• Minimum of 8+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
• Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications.
This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.
In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.
Drug testing may be required; please contact a recruiter for more information.
#1158574 - Laurie McComb