LES Digital Transformation Developer

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting

Job Description

Summary:

The Sample Manager LIMS LES Developer will be responsible for the development, implementation, and maintenance of the Laboratory Information Management System (LIMS) and Laboratory Execution System (LES). This role involves working closely with laboratory personnel, IT staff, and other collaborators to ensure the systems meet the needs of the laboratory and align with regulatory requirements.

Essential Functions: 

• Develop, configure, and maintain Sample Manager LIMS and LES to support laboratory workflows.
• Collaborate with laboratory personnel to understand their needs and translate them into system requirements.
• Design and implement custom scripts, reports, and interfaces to enhance system functionality.
• Perform system validation and ensure compliance with regulatory standards (e.g., FDA, ISO).
• Provide technical support and troubleshooting for LIMS and LES users.
• Conduct training sessions for laboratory staff on the use of LIMS and LES.
• Manage system upgrades, patches, and enhancements.
• Develop and maintain system documentation, including user manuals and SOPs.
• Ensure data integrity and security within the LIMS and LES.
• Participate in cross-functional teams to support laboratory projects and initiatives.

REQUIRED QUALIFICATIONS

Education:

University Degree in a chemistry or related field of study.

Experience:

3 years of LIMS experience with exposure to LES or LIMS Automation

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Good proficiency using Microsoft Office suite tools (MS Word, MS Excel).  Good understanding of basic chemistry and experience with common laboratory equipment and operation.   Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Proficiency with the English language. Works well independently and in a team environment.

Standards and Expectations:   

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.  Consistently strives to improve skills and knowledge in related field.    

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.