Maintenance Specialist

3 weeks ago


Petersburg, Virginia, United States Civica Rx Full time
About Civica Rx:

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. As a leading manufacturer of essential generic sterile injectable medications, we are committed to providing high-quality products while ensuring the safety and effectiveness of our operations.

We are seeking a skilled Maintenance Specialist - Sterile Fill Finish Equipment Expert to join our team at our Petersburg site. This individual will be responsible for supporting manufacturing with equipment maintenance, troubleshooting, and repairs on process equipment, including Fillers with integrated Isolators, ATEC processing, Terminal Sterilizer, Parts Washers, Autoclaves, Single-Use Technology, and Aseptic Process Simulations.

The ideal candidate will have a strong background in sterile fill finish equipment maintenance, with experience in a pharmaceutical industry setting. They will possess comprehensive knowledge of GMP and industry best practices, as well as excellent communication and problem-solving skills.

Key Responsibilities:
  • Ensure a safe and effective working environment.
  • Support manufacturing with equipment maintenance, troubleshooting, and repairs on process equipment.
  • Participate in FAT, SAT, and other activities with equipment vendors.
  • Makes recommendations on equipment upgrades.
  • Recommends, orders parts, and installs machine modifications.
  • Assists with plant safety programs and safety awareness.
  • Prepare and update Preventative Maintenance (PM) tasks relating to production equipment maintenance needs.
  • Assures smooth or improved operation of production equipment by means of any of the following: planning and coordinating maintenance functions with supervisors, Senior Production Operators, and engineering personnel; using historical data to establish and monitor preventive and predictive maintenance procedures; troubleshooting and/or repairs.
  • Prepares purchase requisitions for spare parts used on production equipment as needed.
  • Ensure all work carried out and equipment installed is safe, effective, and in compliance with the appropriate industry standards.
  • All other duties on an as-needed basis, including but not limited to shutdown support and project support.
  • Train and teach others how to perform basic routine maintenance operations.
  • Develop or adapt new processes and procedures for the work area to improve performance and increase efficiency.
  • Analyze Preventative Maintenance routines and ensure appropriateness and value.
Requirements:
  • Experience in a sterile fill finish required.
  • Requires a high school diploma or GED and a minimum of 4+ years of applicable experience in the pharmaceutical industry.
  • Knowledge of GMP and industry best practices.
  • Ability to complete all paperwork neatly, correctly, and in accordance with Company guidelines.
  • Proficient in training others on general maintenance skills.
  • Must be able to communicate, speak/write, and comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals.
  • Effective organization skills and attention to detail.
  • Basic math skills to perform required calculations.
  • Visual ability to detect defects.
  • Work schedule adjustments may be required.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
Preferred Qualifications:
  • Experience with ATEC, Terminal Sterilizers, Parts Washers, and Autoclaves.
  • Associate's degree in a technical discipline, technical school / Auto Mechanic Program certificate.
  • Experience in a process improvement environment, including change management.


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