Senior Automation Specialist I

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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

Education

• Bachelors degree or equivalent and relevant formal academic / vocational qualification

Experience

• 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

Knowledge Skills Abilities

• 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 molecular genomics and biomarker related concepts workflows and technologies (as applicable)

• Work is performed in a laboratory and/or a clinical environment with rare to daily exposure to electrical office equipment irritants radiation toxic materials biological fluids fluctuating and/or extreme temperatures and hazardous waste
• Personal protective equipment such as protective eyewear garments and gloves may be required at times
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists to operate lab equipment
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Standing walking and twisting of upper body/neck required constantly. Crouching/stooping required daily. Kneeling and pushing/pulling of items required frequently. Ability to work in an upright and /or stationary position for 6-8 hours per day
• Light to moderate lifting and carrying (or otherwise moves) objects with a maximum lift of 15-20 lbs.
• Ability to communicate information and ideas so others will understand and to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to acquire or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task