Perform scheduled services and advanced level troubleshooting/service of unscheduled work on specialty equipment, instruments and systems specific to the pharmaceutical Research & Development industry. Possess in-depth technical knowledge requirements for performing complex analytical service procedures, instrument qualifications and calibration tasks. Previous work in a GMP environment desired on tablet press and capsule making equipment.
ESSENTIAL DUTIES and RESPONSIBILITIES
Performs or oversees any in-house services required for instruments that are not currently covered by existing standard operating procedures/guidelines. Documents all work performed to ensure compliance with Good Manufacturing Practices (GMP), Good Lab Practices (GLP) and other applicable Food and Drug Association (FDA) regulations. Recognizes out of tolerance conditions and initiate corrective action and documentation. Assist in training other technicians. Performs calibration and functional checks using a combination of chemical, mechanical and electronic standards. Prepares chemical test standards per applicable Standard Reference Material publications (NIST or equivalent). Monitor standard viability and initiate corrective actions based on analytical evaluations. Performs advanced level repairs/upgrades/troubleshooting beyond what is accomplished during a routine calibration or preventive maintenance or service. Performs modifications to analytical equipment to make them more compatible with specific user defined applications. Develops and writes instrument procedures relating to calibration, calibration limits and interval assessment, preventive maintenance or other documentation for pharmaceutical R&D analytical services. Records and reports abnormal function of equipment or out of tolerance conditions and initiates corrective action. Assists in evaluating cost saving opportunities via internalization of tasks, part reconditioning, and changing vendors. Locates part sources, estimates costs and prepares requisitions. Communicates with customer staff and outside contractors in the calibration, repair and operation of equipment necessary and coordinates with outside contractors regarding repairs covered by maintenance agreements. Complies with company policies and procedures and adheres to company standards. Performs work in accordance with approved equipment calibration, maintenance and safety procedures. Overtime and emergency after hours work on Analytical lab equipment and related systems are required at times. Performs other duties as required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE
High school diploma or general education degree (GED) and a minimum of one year of instrumentation and calibration experience. Associates degree preferred. Background in analytical instrumentation support preferred. Three years of instrumentation and calibration experience preferred. Working understanding of FDA regulations, GMP's, and GLP's.
CERTIFICATES and/or LICENSES
May require valid driver's license.
Ability to comprehend and interpret instructions, short correspondence, and memos and ask clarifying questions to ensure understanding. Ability to write routine reports and correspondence. Ability to respond to common inquiries or complaints from clients, co-workers, and/or supervisor.
OTHER SKILLS and ABILITIES
Knowledge and capability to perform daily work activities with computer programs such as CMMS work order data base system, Microsoft Office including Outlook, Word, and Excel. Must be physically able to perform basic maintenance tasks to the highest caliber, which includes ability to lift objects weighting up to 50 lbs. Must be a team player committed to working in a quality environment. May require experience specific to the pharmaceutical Industry R&D. May require the making of chemical standards using appropriate techniques for weighing, pipetting, mixing, diluting, and verifying concentrations.
Responsible for personal safety and the safety of those who are affected by your work. This includes but is not limited to:
Complete all required and assigned HSE training at a satisfactory level
Follow all activity policies and procedures, including all HSE-related requirements at all times
Participate in all HSE-related programs & activities as required, including incident investigations, interviews, auditing and assessment, etc.
Report any conditions which you feel could result in an accident or injury and / or stop work if required
Internal Number: 19017487
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