We are seeking a Metrologist for the Schaumburg site. The Sr. Metrologist will perform duties of developing, establishing, and maintaining equipment calibration and qualification methodologies, systems, and practices that meet (SAI) and regulatory requirements. Identifies magnitude of error sources contributing to the uncertainty of results to determine the reliability of measurement process in quantitative terms. Redesigns or adjusts measurement capability to minimize errors. Develops and enhances calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements.

Assists engineering, quality, manufacturing, and laboratory personnel to design, manufacture, evaluate, and calibrate measurement standards, instruments, and test systems to ensure the selection of approved instrumentation. Advises others on methods of resolving measurement problems and performs training to SAI personnel. Performs investigations into equipment calibration and maintenance failures to determine product impact.

Job Functions:

• Embraces a "team" working environment focused on achieving department goals by demonstrating a willingness to accept assignments not explicitly listed in the job description as allowed by the limitations of training, experience, and/or education.
• Demonstrates and promotes accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety, and teamwork.
• Executes against project plans and goals as assigned by Quality Management.
• Meets productivity, quality, and teamwork metrics for the level of the position.
• Functions as a subject matter expert (SME) within Metrology and provides support to all departments.
• Monitors Metrology resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed contracted resources.
• Works independently and can facilitate non-routine assignments.
• Mentors and develops staff to maximize staff performance and objectives.
• Works in collaboration with other departments to evaluate and recommend improvements to equipment and processes associated with laboratory, manufacturing, and clean utility activities.
• May manage inter-departmental projects to ensure timely completion of objectives.
• Maintains the utmost level of confidentiality at all times.
• Performs instrument/method troubleshooting within analytical method parameters.
• Writes, revises, reviews, and implements technical documentation, including protocols, reports, reference equipment qualification reports, and change controls.
• Reviews Metrology calibration and maintenance documentation for compliance with cGMPs, compendia requirements, and (SAI) procedures/protocols.
• Reviews and/or writes technical reports, procedures, investigations, and protocols.
• Drive continuous improvement using metrics for instrument repair history and response time.
• Identify equipment constraints due to equipment downtime and maintenance schedules and provide recommendations to Operations personnel for minimizing impacts.
• Provides problem-solving skills to support the resolution and documentation of investigations for laboratory, manufacturing, clean utility, and equipment issues.
• Concludes data and communicates those conclusions in writing.
• Determines root causes of non-conformance and recommends corrective action. Ensures timely closure of investigations.
• Documents, develop, and apply strategies to ensure scientific objectives by monitoring/evaluating the completion of tasks.
• Establishes policies, procedures, and practices associated with Metrology activities, including safety, testing, scheduling, and documentation.
• Maintains and improves GMP compliance and documentation.
• Performs training and supervises staff in the use of instrumentation and equipment.
• May perform internal and external audits of Metrology contract laboratories.
• Communicate with vendors for equipment quotation and generate equipment purchase requisition.
• Completes any other duties assigned for the Schaumburg site.
• Assists in maintaining Calibration Database, preparing and assigning calibration assignment in-house or through certified contracted Metrology Laboratories.

Education:

• Minimum of Bachelor's Science degree or a Certified Engineering Technologist with the related field of seven to ten years of appropriate professional experience.
• Minimum 7 years of experience
• Working at a Pharmaceutical company is a plus.
• Requires a body of knowledge of principles, procedures, methods, and techniques in a specialty, including analytical chemistry laboratory equipment, manufacturing equipment, and clean utility instrumentation.
• Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e., HPLC, GC, Dissolution).
• Where appropriate, the candidate must have broad knowledge in USP related to equipment calibration and qualification.
• Good English written and verbal communication skills. Must be highly organized and able to work under pressure. Must have strong interpersonal and leadership skills.
• Must be computer literate with knowledge in all Microsoft business applications. A strong background in scientific software such as Waters Corp. Empower, LIMS, Master Control software, and Blue Mountain Maintenance and Calibration software is a plus.

Benefits:

• Comprehensive insurance coverage that includes Medical, Vision, and Dental benefits.
• Company Paid Life & AD&D and Supplemental Life Insurance
• Short Term & Long Term Disability Insurance
• Flexible Spending and Health Savings Accounts
• Pet, Legal and Identity Theft Insurance Plans
• Employee Assistance Program
• 401K retirement plan with 5% employer match (Pretax and Roth options)
• 401k profit sharing contribution based on company performance.
• Paid holidays and generous paid time off.
• Competitive annual bonus

Employee Perks:

• On-site café
• On-site Fitness Center
• Employee Discounts on GUM products
• Holiday Lunches
• Lunchtime Barbeques
• Ice Cream Socials
• Fall Festival
• Miles of beautifully maintained walking trails.
• Numerous employee appreciation events throughout the year.
• Professional development and training classes

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)