Instrument and CSV Engineer I

Tolmar Careers • Windsor, CO

1d • $70,000 - $75,000

About The Position

The Instrument and CSV Engineer I supports laboratory instruments and computer systems validation activities under general supervision. This role focuses on documentation, protocol execution, and learning regulatory expectations.

Requirements

• Knowledge of software administration, user account creation, and computer system validation.
• Effective oral and written communication skills.
• Ability to work both independently and as part of a cross-functional team.
• Knowledge of CSV/CSA principles, cGMP practices, regulatory and ICH guidelines.
• Knowledge of Microsoft Office Suite, and various GxP software packages.
• Knowledge of database design and maintenance, and laboratory software programs.
• Ability to troubleshoot and implement problem-solving skills.
• Ability to manage multiple projects concurrently and under tight time constraints.
• Ability to adapt to shifting priorities and operate with a sense of urgency while maintaining high quality.
• Bachelor’s degree required, preferably in Computer Science, Engineering, and/or Life Sciences.
• Some experience with software applications and/or in an analytical laboratory.
• Knowledge of software administration, user account creation and maintenance, and computer system validation.
• Experience with validation computer systems gained through formal academic studies or work experience.

Responsibilities

• Assist in developing and executing validation deliverables (IQ/OQ/PQ) for lab instruments and GxP computer systems including upgrades and revalidation.
• Work with instrumentation and computer system vendors to verify validation criteria and data integrity requirements are met.
• Support data collection, deviation documentation, and report generation for the Validation team.
• Follow established procedures and templates for validation deliverables.
• Complete assigned change actions for validation projects within defined timeframes.
• Participate in instrument and system testing and verification activities.
• Collaborate with QA, laboratory staff and IT to ensure compliance with 21 CFR Part 11 and data integrity and regulatory standards.
• Adheres to company and departmental timelines with high accuracy and quality.
• Maintain an atmosphere of teamwork, cordiality, and respect towards co-workers.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage.
• Respond to spills per the Chemical Spill Procedures.
• Perform other duties as assigned.

Benefits

• Benefits summary: https://www.tolmar.com/careers/employee-benefits
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees