Maintenance Technician, Process Equipment (# 318, # 605)

BioSpace; Petersburg (VA); Sur place; USD 39 000 - 52 000; Plein temps

Résumé du poste

Civica is seeking a Maintenance Technician, Process Equipment, to ensure compliant production in a GMP pharmaceutical environment. The role covers lines, isolators, autoclaves, washers, and other process equipment, with focus on safe, reliable operation.

The ideal candidate has strong troubleshooting skills, experience with sterile manufacturing, and the ability to work autonomously in a fast-paced setting.

Qualifications

• High school diploma with 4 years of maintenance experience in manufacturing.
• Experience with sterile fill-finish manufacturing and GMP.
• Strong communication, collaboration, and autonomous work in a GMP setting.

Responsabilités

• Support day-to-day production activities; first line in equipment malfunctions.
• Provide technical support to production teams with Engineering and calibration.
• Coordinate preventive maintenance and calibrations with spare parts teams.
• Troubleshoot equipment with owners, engineers, and vendors to reach solutions.
• Complete GMP paperwork and documentation accurately and timely.
• Adapt priorities to changes in the production schedule; participate in on-call rotation.

Connaissances

Autonomy

Communication skills

Collaboration

Sterile manufacturing

GMP knowledge

Troubleshooting

CMMS

Formation

Associate degree or higher in Pharmaceutical Sciences or Engineering

Outils

CMMS

Description du poste

About Civica

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

About Civica

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at www.civicarx.org

Position Summary

The Maintenance Technician, Process Equipment is responsible for driving compliant results in a GMP pharmaceutical manufacturing environment by directly supporting a wide range of service disciplines covering pharmaceutical process equipment such as, but not limited to: fill lines, isolators, parts washers, autoclaves, container closure processing equipment, formulation vessels, labeling equipment, and various lab equipment utilized in the production environments. The Maintenance Technician, Process Equipment, operates in a highly technical environment that requires experience specifically in maintaining safe and reliable production activities. The Maintenance Technician, Process Equipment, applies critical thinking and considers all business-impact factors before taking job-related actions that could lead to unintended consequences, such as unsafe events, equipment failure, and other risks. The Maintenance Technician, Process Equipment, should be able to apply independent judgment and perform in a small-company environment where rapid changes occur. The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive mindset, driving a positive team culture.

These positions follow a 2-2-3, 12-hour day schedule: 6:00 PM-6:30 AM - 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off.

Essential Duties And Responsibilities

• Support the day-to-day production activities in the production area. First line of response in case of production equipment malfunction.
• Provide technical expertise and support to production teams, addressing issues and challenges as they arise while working closely with Engineering and other support teams.
• Partner with engineering, calibration, and spare parts teams to ensure proper inventory of key spare parts.
• Partner with engineering in the development and/or revision as required, of preventive maintenance (PM) instructions of production equipment.
• Support the coordination and execution of calibrations and preventative maintenance activities.
• Troubleshoots equipment as necessary, working with equipment owners, engineers, and equipment vendors as needed to reach problem resolutions.
• Proactively work with supports teams Ein developing solutions for equipment issues.
• Completes required paperwork and documentation, work orders and GMP documents in a clear, accurate and in a timely manner.
• Develop and encourage good interpersonal working relationships among Facilities staff and with other customer departments (internal and external).
• Collaborate with Manufacturing, Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
• Support the onboarding and technical training of Manufacturing staff on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, ATEC commodities processing, Parts Washers, Autoclaves, Single-Use Technology, and formulation vessels.
• Assist R&D and MSAT on new product introduction and technology transfer activities.
• Assist in the revision and management of manufacturing documents such as Batch Records and SOPs.
• Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions to minimize impact on operations.
• Periodically on call to monitor and respond to manufacturing equipment repairs and issues.
• Other duties as assigned.

Basic Qualifications (Knowledge, Skills, And Abilities)

• High school diploma with 4 years of experience in executing maintenance to manufacturing equipment, or an associate’s degree or higher in Pharmaceutical Sciences, Engineering, or a related field is preferred.
• Experience with sterile fill-finish manufacturing.
• Knowledge of GMP, regulatory requirements, and industry best practices.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Experience in a continuous process improvement environment, including change management.
• Experience in using Computerized Maintenance Management Systems.
• Strong communication and collaboration skills, committed to meeting high-quality standards.

Preferred Qualifications

• Knowledge of high-speed aseptic filling and isolator barrier system technology.
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Proficiency in Microsoft Office Suite.

Physical Demands and Work Environment

The physical demands described here are those an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions. While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee must frequently use their hands or fingers to handle, feel, or control objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an equal opportunity employer, a drug-free workplace, and complies with applicable ADA regulations.