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Position Summary
The GMP Engineer is responsible for assisting in company-wide compliance to all applicable regulatory requirements and assisting with the day-to-day operations of the laboratory’s GMP equipment validation program.

Job Responsibilities

• Collaborate and assist departments with GMP equipment validations to achieve and maintain company-wide regulatory compliance and operational efficiency.

• Ensure equipment qualification protocols are executed and completed in a timely fashion.

• Support system owners in validation planning, protocol development, and execution.

• Manage projects related to asset management, qualification, and re-validation on a routine basis.

• Ensure adherence to GMP and safety procedures.

• Author, review, revise, and implement system validation documentation in line with GMP requirements.

• Manage company records in accordance with regulatory requirements and company policies.

• Use problem solving skills to identify and solve problems or improve processes.

• Help train other team members on job functions, where applicable.

Required Qualifications

• Bachelor’s degree in a scientific discipline with a minimum of two years of experience working in a regulated environment (CAP, CLIA, NYS, FDA, ISO, etc.).

• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

Preferred Qualifications

• Previous laboratory technician or equivalent experience.

• Experience reviewing validation documents and executing protocols for equipment used in GMP production.

• Previous experience training other employees on processes.

• Demonstrated knowledge of equipment maintenance best practices relative to validated system and processes in a GxP environment.

• Familiar with GAMP5 principles, ISO 13485, ISO 9001, and other requirements of regulated manufacturing processes.

Physical Demands

• Employee may be required to lift routine office supplies.

• Employee must be able to use standard office equipment.

• While the majority of work is performed in a desk/office environment, employee may be required to spend time in the laboratory and may have exposure to high noise levels, fumes, and biohazardous materials.

• Employee must have ability to sit for extended periods of time.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.