TECH SVCS Benchtop Support Specialist

Job description

Job Title: Benchtop Support Specialist

Scheduled: Flexible to work between 6am and 11pm rotating shifts and on weekends



Top Skills:

- Experience working in a GMP environment

- Experience supporting end user Windows environment

- Comfortable working with AI platforms and can help scale automation capabilities preferred

- Cyber Security Knowledge preferred

- Understanding and experience with Network, databases, servers, and PCs

- Knowledge of Incident, problem, and asset management

- 3+ years of Experience Supporting multiple projects, ability to multi-task .





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.



REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:



" Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.

" Comprehensive knowledge of SOPs, GMP and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory 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.

" The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, 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



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.

" 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.

" Provide on-call support, as needed, for commercial operations.





Working Conditions:

Office and Lab/Clean room environments, PPE required at times.

Physical Demands:

Ability to move computers and monitors from prep room to labs, lifting up to 25lbs.



The starting hourly compensation for this assignment is a range from ** - **.

While the final, individual compensation will be determined by your employer of record (and not client), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed.

The starting hourly compensation may be subject to change.

Additional Job Requirements:



EEO:



Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

Required Skill Profession

Business And Financial Operations