Title:  Metrology Specialist III

Job Summary

Responsible for ongoing metrology support of manufacturing and quality control instruments in a lab environment or on a production floor. Performs, as needed, a variety of installation, calibration, maintenance, troubleshooting, and repair duties on complex laboratory, process and utility instrumentation, working closely with the Maintenance, Operations and Automation groups, following SOPs in a cGMP facility. Utilizes a QMS to document findings of calibrations and provide root cause to deviations from OOT/UPD/OOS situations.

Area Of Responsibility

• Experience calibrating instruments such as, Lyophilizers, Fillers, RO systems, WFI stills, Clean steam generators, Autoclaves, CIP systems, lab equipment, etc.
• Cleanroom, Fillers, BSC, Laminar flow, etc. HEPA certification subject matter expert
• Perform assessments and process improvements to enhance calibration testing methods
• Perform scheduled, new and emergency calibrations activities with vendors on all critical process equipment and lab instrumentation ensuring compliance with SOPs and cGMPs
• Coordinate external calibration vendors to address scheduled, new and emergency calibrations
• Maintain calibration records and instrument tagging
• Write Standard Operating Procedures (SOPs)
• Maintain calibration records and instrument tagging
• Calibrations deviation, CAPA and change control technical writer lead
• Create, Investigation and close QMS records (Deviation, CAPA, Change Control, Process Improvement)
• Serve as calibration technical lead for projects and audits
• Assist in change control documentation and deviation notifications
• Assist in troubleshooting instrumentation issues as needed
• Assist in performing maintenance on lab instrumentation and manufacturing equipment
• Coordinate inventory for spare parts used on critical instruments
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Manufacturing area/clean room area
• Maintenance Shop
• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

• Stand, sit, walk, stoop, climb, use hands and fingers to handle or feel, reach with hands and arms
• Close and distance vision, talk, hear
• Wears personal protection equipment - safety glasses, gloves, gowning
• Use of autoclave
• Operates computer/office machines
• Exposure to noise
• Lift up to 25 lbs.

Travel Estimate

Up to 0 %

Education and Job Qualification

• High school diploma or equivalent is required
• Work under general supervision, utilizing some clearly described procedures and/or general technical knowledge
• Good organizational skills
• Ability to work independently and meet deadlines with minimal supervision
• Excellent verbal, writing and interpersonal communication skills

Experience

• Minimum 6+ years related experience preferred.
• Experience in temperature, pressure, flow (liquid & gas), pH, conductivity, humidity, lab instrumentation controllers, depyrogenation oven, freeze dryer, steam generators, steam boilers, air compressor, vacuum pumps, and lab instrumentation
• Knowledge of pharmaceutical-manufacturing/lab instrumentation environment
• Strong knowledge of Blue Mountain calibration software
• Thorough understanding of metrology principles defined in ASNI/NCSL required
• Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, and ISO standards
• Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation

The presently-anticipated base compensation pay range for this position is $80,000 to $94,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.