Senior Automation Specialist II (Hamilton) - GMP

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

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

Education and Experience: 

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