Performs a variety of sophisticated activities in support of automated instrumentation. Performs tasks following company SOPs and policies, while also adhering to automation standard processes independently. Develops and supports initiatives to increase efficiency and productivity of the laboratory.
Essential Functions and Other Job Information:
Develops and validates scripts/methods. Understands and conforms to methods, and protocols applicable to assigned tasks.
Develops liquid classes for liquid handling workstations and trains others to perform liquid class testing.
Maintenance and complex remedial maintenance (e.g., sophisticated hardware replacements)
Implements new scripts/methods through developmental testing without supervision.
Supports new hires and trainees in completing scripts/methods.
Program scripts with high complexity in support of maintenance activities and/or assay methods on automated instrumentation
Posseses excellent documentation skills and adheres to relevant SOPs and laboratory automation best practices. Trains others on documentation and SOPs/laboratory automation best practicies.
Performs programming and/or process mapping for fully automated workflows
Designs and implements data integrity processes
Provides team coaching/mentorship
Qualifications:
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 4+ 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.
Knowledge, Skills, and Abilities:
Direct experience with automation instrumentation required; vendor service certification 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
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