Senior Metrologist

Activities:

• Performs scheduled routine maintenance on active instrumentation and equipment.
• Performs scheduled calibrations/qualifications on active instrumentation and equipment to include IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification).
• Independently writes and reviews qualification documentation.
• Performs remedial maintenance on active instrumentation and equipment.
• Oversees and manages installation of new laboratory instrumentation and equipment.
• Trains end users on existing instrumentation and equipment as required.
• Prepares SOPs pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment.
• Addresses audits on laboratory equipment and instruments.
• Evaluates lab support records for compliance with SOPs, reviews for completeness and accuracy and reports findings.

Education

• Bachelor's degree in engineering or science field or equivalent and relevant formal academic / vocational qualification

Experience

• Two to five years of previous experience in analytical metrology that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, and experience.

Knowledge, Skills, Abilities

• Understanding of FDA and GXP regulations and requirements
• Working knowledge and understanding of laboratory instrumentation and equipment
• Working knowledge with systems in use at TBI or within the CRO/Pharmaceutical industry
• Ability to train others
• Client focused approach with strong interpersonal skills
• Analytical and critical thinking skills
• Trouble shooting abilities
• Ability to communicate effectively with vendors, clients and all levels of staff
• Ability to work in a collaborative team environment

Physical Requirements / Work Environment

Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information with diverse groups of people.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 50 pounds.
• Able to work in non-traditional work environments.
• Able to use standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous materials, including potent compounds, typically found in a pharmaceutical development laboratory.
• Able to prioritize and handle multiple activities with critical timelines.