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.


Applicants must be legally authorized to work in the United States. Sponsorship not available.


Our client is seeking a Benchtop Support Specialist in Bothell, WA.


Role Description


PURPOSE AND SCOPE OF POSITION: The Benchtop Support specialist position will be responsible for providing IT support in our Digital Plant organization working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within the manufacturing, quality, and quality control organizations. This position requires a passion for IT, validation, and compliance. Project management and business analyst skillsets within the role as the position requires the ability to work with diverse cross-functional teams in a highly matrix organization. The candidate should have at least 5 years of experience in pharma/biotech with experience in Laboratory equipment, benchtop instrumentation and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing enterprise systems support.


DUTIES AND RESPONSIBILITIES:
• 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 client 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 client 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 CLIENT directives and industry guidelines for applications.
• Execute on technology improvements and efficiency opportunities to improve business and compliance.


Skills & Requirements


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


Top Skills: - Cyber Security Knowledge preferred - Understanding and experience with Network, databases, servers, and PCs - 3+ years of Experience Planning and leading small and medium-sized projects preferred. - 3+ years of Experience Supporting multiple projects, ability to multi-task preferred. - Knowledge of Incident, problem, and asset management


• 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.
• 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 preferred.
• Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications


Benefits/Other Compensation


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).


Why Hays?


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.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


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.


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#1166931 - Laurie McComb