Instrument and CSV Engineer I

Core Hours

Monday - Friday, 8:00 am - 5:00 pm

Purpose and Scope

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.

Essential Duties & 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.

Core Values

This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Knowledge, Skills & Abilities

• 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.

Education & Experience

• 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.

Working Conditions

• Working conditions include general office environment, and laboratory settings; will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Business demands may require working extended hours.

Compensation and Benefits

• Pay: $70,000 - $75,000 depending on experience
• 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. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.