Sr Automation Specialist - CSD Focus

Thermo Fisher Scientific•Richmond, VA

17h•Onsite

About The Position

Position : Senior Automation Specialist I Location : Richmond, VA Department: CSD Shift: First Shift - Monday - Friday, 8AM - 5PM EST Full time, Benefits, Annual Bonus, 401k Match, and PTO This is a fully onsite role based at our BIOA Laboratory in Richmond, VA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale! Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. A day in the Life: Independently performs program optimization and validation of complex scripts. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and executes experiments independently. Reviews and critiques automated instrumentation programs and associated documentation and other related technical documents. Communicates data, technical issues, information regarding project definitions and expectations, and discussions of project status to interested parties as needed Provides technical guidance Leads analytical (procedural and instrumentation-related) troubleshooting sessions Assists in preparation and implementation of SOPs and quality systems. Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP). Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers. Evaluates available technical options to acquire desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical application. Communicates status of project efforts to manager. Provides leadership and mentoring to team members in order to improve their technical expertise and scientific knowledge. Implements novel approaches to method development and applications as appropriate. Provides training/orientation to production staff as needed to efficiently implement methods. Assists in startup and troubleshooting methods through the first analytical application and as needed in future projects. Complex remedial maintenance (e.g., complex hardware replacements) Performs programming and/or process mapping for fully automated workflows Implements data integrity processes; supports instrument software validation efforts Plans and schedules preventative maintenance

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Or Master degree with 4+ years of experience Or PhD with 2+ years of experience
Direct experience with automation instrumentation required; vendor certification preferred
Experience with programming (Hamilton Venus, TECAN EVOware or Fluent Control, Thermo Momentum, VB, Python, etc.) required; vendor programming certification (or equivalent) preferred
Proficient in Microsoft Excel and Word
Proven time management, troubleshooting, and critical thinking skills
Proven record of working in a collaborative work environment with a team
Proven understandonf of GxP requirements, SOPs, ICH guidelines, USP requirements, and FDA guidance
Ability to interpret data by performing trend analysis
Proven ability to train or provide mentorship to other automation staff for programming, system optimization, validation/qualification requirements, etc.
Knowledge of data generation and statistical programs
Knowledge of general chemistry, chromatographic sciences, and biomarker related concepts, workflows and technologies (as applicable)
Familiarity with various Mass Spectrometry techniques and instrumentation

Responsibilities

Independently performs program optimization and validation of complex scripts.
Understands and conforms to methods, and protocols applicable to assigned tasks.
Designs and executes experiments independently.
Reviews and critiques automated instrumentation programs and associated documentation and other related technical documents.
Communicates data, technical issues, information regarding project definitions and expectations, and discussions of project status to interested parties as needed
Provides technical guidance
Leads analytical (procedural and instrumentation-related) troubleshooting sessions
Assists in preparation and implementation of SOPs and quality systems.
Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.
Evaluates available technical options to acquire desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical application.
Communicates status of project efforts to manager.
Provides leadership and mentoring to team members in order to improve their technical expertise and scientific knowledge.
Implements novel approaches to method development and applications as appropriate.
Provides training/orientation to production staff as needed to efficiently implement methods.
Assists in startup and troubleshooting methods through the first analytical application and as needed in future projects.
Complex remedial maintenance (e.g., complex hardware replacements)
Performs programming and/or process mapping for fully automated workflows
Implements data integrity processes; supports instrument software validation efforts
Plans and schedules preventative maintenance