Senior Automation Specialist II (Hamilton) - GMP

Thermo Fisher Scientific•Middleton, WI

11d•Onsite

About The Position

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance will be provided for this position. Must be legally authorized to work in the United States. 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. Summarized Purpose: Conducts and provides technical guidance on the development, qualification, and/or validation work in support of automated instrumentation and/or performs troubleshooting for own and others projects and/or automated instrumentation. Routinely acts as the technical project leader for multiple projects, interacts with clients as needed, reviews and evaluates data, and writes technical documents. Designs and executes development, qualification, and/or validation work independently and interprets and reviews analytical data for self and others. Plans appropriate experiments and schedules resources and work hours to meet expected completion dates.

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 7+ 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 service certification preferred
Experience with Hamilton and Tecan Automated Liquid Handler Platforms and associated programming (Hamilton Venus, TECAN EVOware or Fluent Control, Thermo Momentum, VB, Python, etc.) required; vendor programming certification (or equivalent) preferred
Ability to operate and troubleshoot a wide variety of analytical instrumentation and data acquisition systems
Ability to handle multiple tasks and priorities
Proven track record to work in a collaborative work environment with a team
Proven understanding of GxP requirements, SOPs, ICH guidelines, USP requirements and FDA
Proven troubleshooting and critical thinking skills
Proficient in complex automated platform software use and programming
Proven ability to train other automation staff for programming, liquid class testing, labware testing, etc.
Knowledge of data generation and statistical programs
Knowledge of general chemistry, separation science, immunochemistry, molecular genomics, biomarker, and/or vaccine science related concepts and/or technologies (as applicable) systems
Technical writing skills
Effective communication (written and oral) and organizational skills
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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.
Writes, reviews and critiques automated instrumentation programs and associated documentation and other related technical documents for self and others.
Communicates data, technical issues, information regarding project definitions and expectations, and discussions of project status to stakeholders as needed
Provides technical guidance and team coaching/mentorship
Leads analytical (procedural and instrumentation-related) troubleshooting sessions
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).
Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical application.
Provides leadership and mentoring to team members in order to improve their technical expertise and scientific knowledge.
Creates and implements novel approaches to automated method development and applications as appropriate
Provides training/orientation to production staff as needed to successfully 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); manages instrument fleet
Performs programming and/or process mapping for fully automated workflows; participates in design of systems