Instrumentation Specialist I

Purpose and Scope

Perform aspects of laboratory instrumentation including maintenance, calibrations, performance verifications, and troubleshooting in compliance with cGMP and regulatory requirements.

Essential Duties & Responsibilities

• Performs routine maintenance, troubleshooting, and qualification of laboratory instrumentation/equipment.
• Reviews maintenance, troubleshooting, and qualification of laboratory instrumentation/equipment for appropriate documentation.
• Schedules onsite vendor repair, qualification, service, and verification when needed.
• Conducts user access reviews, and audit trail reviews for various firmware and software-based instrumentation/equipment.
• Assists in the inventory and ordering of parts, supplies, and consumables required for the performance of maintenance, repair, and verification of laboratory equipment and instruments.
• Trains analysts in proper instrument care.
• Performs documentation of all activities and maintains records according to good documentation practices.
• Provides detailed accounts of activities performed to investigators. Under the direct supervision of an investigator, may perform investigational activities.
• Makes scientific recommendations to management/technical writers regarding procedures and work instructions.
• Completes assigned tasks on time and works to eliminate repeat errors. Ensures strict adherence to all procedures applicable to job functions to ensure high quality of work.
• Prioritizes tasks and performs job duties with minimal guidance from management. Works to complete tasks efficiently and is a productive member of the department. Contributes to a highly productive environment by avoiding distractions.
• Assists in the validation activities, such as installation, operation, and performance qualifications on typical instrumentation (HPLC, GC), when required.
• Ensures that company and regulatory data integrity guidelines are consistently followed.
• Accountable for maintaining an atmosphere of teamwork and respect towards co-workers.
• Interacts respectfully with all other employees both inside and outside of the department and members of management and shows interest in others' input and reasoning. Appropriately resolves differences of opinion. Upon delegation may be responsible for representing the Engineering department when communicating with outside departments and vendors.
• Identifies issues and escalates those issues to the department senior leadership or management as appropriate.
• Provide support to the department leadership with implementing new systems and continuous improvement efforts. Generates and supports new ideas to create efficiencies and process improvements and enhancements.
• 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.
• Performs additional duties as assigned.

Knowledge, Skills & Abilities

• Experience in a government regulated laboratory environment, preferably for drugs or medical devices including cGMP, GLP and ICH and their application to laboratory testing and review processes and procedures.
• Effective written and oral communication skills.
• Ability to use and maintain analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.
• Knowledge of computer systems for laboratory equipment, raw data handling and storage.
• Ability to interpret, understand and follow analytical procedures/calculations and scientific principles.

Core Values

The Instrument Specialist I 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.

Education & Experience

• Bachelor's degree in scientific discipline, preferably in Chemistry or Biochemistry.
• Two or more years of experience in an analytical laboratory position.

Working Conditions

• Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Moderate Lifting of equipment parts and modules.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours.

Compensation and Benefits

• Pay: $65,000 to $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.