Senior Automation Specialist I - Molecular
About The Position
This is a fully onsite role based at our BioAnalytical 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. The working schedule for this role is Monday - Friday from ~8AM-5PM. 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. Location/Division Specific Information Molecular Genomics - Automation Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic authorities. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
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). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- 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 understanding 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, molecular genomics, and biomarker related concepts, workflows and technologies (as applicable)
Nice To Haves
- vendor certification preferred
- vendor programming certification (or equivalent) preferred
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
Benefits
- Relocation assistance is not provided
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What This Job Offers
Job Type
Full-time
Career Level
Senior
