FEQ Instrumentation and Controls Technician in Lexington, KY at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

Job Description


POSITION DESCRIPTION

Position Title: Instrumentation and Controls Technician

POSITION SUMMARY

The role of the Instrumentation and Controls Technician is to provide the necessary knowledge and skill sets needed to properly and efficiently calibrate, maintain, troubleshoot and repair clients cGMP process, facility, and laboratory equipment and instrumentation. This position is also responsible for working across departments to coordinate the timely completion of routine and non-routine calibration and the maintenance, documentation of all activities per the required procedures and processes.

PRIMARY RESPONSIBILITIES

  • Under guidance of the Maintenance Supervisor, primarily responsible for performing routine and non-routine calibration of client's critical, non-critical, and safety related instruments used to support cGMP process manufacturing, packaging, facility and other material testing processes.
  • Clients cGMP process manufacturing equipment includes but is not limited to an autoclave, depyrogenation oven, lyophilizer, parts washer, vial washer, Water for Injection and Purified Water System, and other misc process support equipment. client's laboratory equipment includes but is not limited to temperature and humidity controlled stability chambers and chart recorders, timers, and temperature indicators.
  • Must maintain a high level of instrumentation and controls knowledge, skills and experience in order to thoroughly assess any problems with the equipment and systems, identify the problems, make the necessary repairs and then complete all associated cGMP documentation needed to appropriately document the work performed (e.g. work orders, change controls, etc).
  • A high level of knowledge and skill utilizing tools such as multimeters, temperature measuring standards, humidity measuring standards, pressure standards, etc. is required
  • Possess personnel skills needed to work across clients departments (and associated department management) to coordinate routine and non-routine activities within the master production schedule, work closely with Operations personnel to obtain information needed to assess equipment problems in a courteous / professional demeanor, as well as coordinate and oversee the work of vendor technical personnel.
  • Assist in establishing and maintaining any necessary procedures and processes required to perform routine calibration equipment and systems throughout the plant. This includes but is not limited to establishing calibration procedures / tasks, establishing and maintaining appropriate calibration schedules and intervals, reviewing / enhancing calibration procedures when required and identifying improvements to existing calibration processes in order to ensure peak performance of the process equipment.
  • Will also be required to participate in cross functional teams that may be required to identify assignable root causes for any product or equipment related deviations or anomalies, and then establish and implement the necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future.

Other essential functions this position are as follows:

  • Perform all activities in compliance with company cGMP and safety policies, procedures and practices.
  • Responsible for conveying the Company's attitude towards quality, policy and standard operating procedures, throughout the department.
  • Assist in supervising activities contractors when appropriate.
  • Effectively communicate with Directors, Managers and peers. Notify management or other qualified personnel if specifications cannot be met and/or quality or safety is being compromised.
  • Expertly operate tools such as PCs and various interface hardware and software to support automation platforms/components such as PLCs and HMIs.
  • Perform advanced level repairs and troubleshooting.
  • Develop and write equipment calibration procedures.
  • Maintain calibration database as required.
  • Communicate if any safety equipment is not functional.
  • Exercise technical, mechanical and control system aptitude / skills in order to accurately identify root causes for machine failures or break downs and the repair accordingly.
  • Adhere to company policies and procedures.
  • Read, understand and comply with SOP's.
  • Read and understand technical information provided in equipment manuals and any associated electrical or mechanical drawings.
  • Read and understand PLC (programmable logic controller) control logic, as well as other configurable controllers such as VFDs, relay logic, etc.
  • Maintain work areas in a neat, organized and uncluttered state
  • Document all activities as required by SOP, Policy or other work instruction.
  • Deliver all services with a craftsman like manner and quality.
  • Overtime work may be required during standard shifts or on weekends to assure production schedules are met, as well as maintain PM schedules.
  • Work on other projects as requested by management.
  • Stay current with evolving plant technology.
  • Must be physically capable of climbing ladders, working with minute hardware, working in a lying position, working with arms extended overhead.
  • Must be physically capable of using a respirator and other personal protection devices/equipment.

QUALIFICATIONS

  • Requires: High school diploma or equivalent.
  • Highly Desirable: Associate's degree in Engineering Science or Engineering Technology or related discipline.
  • 5 years of hands-on calibration, instrumentation and electronic equipment/controls maintenance experience.
  • 5 years in the pharmaceutical or related industry or equivalent combination of education and experience may substitute.

WORK ENVIRONMENT

  • Laboratory/manufacturing setting with exposure to dust, odor, noise, and fumes may be present.
  • Frequent sitting, talking, or hearing.
  • Must occasionally lift and/or move up to 50 to 75 pounds.

Must use hands to handle, feel, reach or operate objects or controls.

CONTACT: Julie Ford, jlford@apexlifesciences.com // 847-678-5171

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.