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GMP Maintenance Technician

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO).  As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!


As a GMP Maintenance Technician you will play a vital role in ensuring the safe, efficient, and compliant operation of our production equipment in an aseptic environment. This position involves maintaining, troubleshooting, and repairing equipment and systems within a cGMP-regulated environment, while adhering to strict industry standards and regulatory requirements. The role requires technical expertise, attention to detail, and a strong understanding of GMP and FDA guidelines to ensure continuous operation and product quality.


Responsibilities
  • Execute preventive and corrective maintenance activities on GMP equipment, including vial/syringe, bag filling stations, formulation, and packaging. 
  • Identify and address any mechanical, electrical, or instrumentation issues that could affect production timelines or product quality. 
  • Perform all maintenance work in compliance with GMP, SOPs, and regulatory guidelines.  
  • Complete and maintain accurate documentation of all maintenance activities, including work orders, logs, calibration records, and equipment history. 
  • Execute preventive maintenance activities to minimize downtime and ensure equipment reliability. Report any required corrective actions or replacements to management. 
  • Conduct regular inspections of production equipment and facilities to identify potential issues, ensuring that all systems are operating efficiently and in compliance with regulatory standards. 
  • Assist in commissioning and qualification activities for new equipment installations. 
  • Maintain a consistent production floor presence in support of all production activities and participate in all production tier meetings between shifts.  
  • Adhere to all company and regulatory safety standards, including those related to hazardous materials, electrical safety, lockout/tagout procedures, and PPE usage. 
  • Collaborate with Engineering, Operations, and Quality teams to drive continuous improvement initiatives and to ensure equipment readiness and resolution of any issues that may impact production schedules or product quality. 
  • Complete work orders assigned by the required SLAs.  


Qualifications
  • Education: High School diploma or equivalent required. Technical certification in industrial maintenance, HVAC, electrical, or a related field preferred.
  • 2+ years of experience in equipment maintenance or facilities management within a GMP-regulated environment, preferably in a pharmaceutical, biotechnology, or CDMO setting.
  • Experience with troubleshooting and maintaining manufacturing systems.
  • Familiarity with validation, qualification, and calibration processes in a GMP environment.
  • Strong understanding of GMP regulations, SOPs, and FDA guidelines.
  • Hands-on experience with mechanical, electrical, and instrumentation troubleshooting and repair.
  • Ability to read and interpret technical manuals, blueprints, and schematics.
  • Knowledge of safety standards and procedures in a regulated environment.
  • Good understanding of aseptic technique.  
  • Strong problem-solving skills and attention to detail.
  • Ability to work independently and as part of a team in a fast-paced environment.


Physical Requirements
  • Ability to lift and move up to 40 lbs. 
  • Ability to work in various environments, including confined spaces and heights. 
  • Ability to stand, walk, kneel, or bend for extended periods of time. 
  • Previous experience in a Contract Development and Manufacturing Organization (CDMO) or similar environment. 


At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

 

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!


August Bioservices  is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

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Average salary estimate

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What You Should Know About GMP Maintenance Technician, August Bioservices

At August Bioservices, headquartered in Nashville, Tennessee, we're on the lookout for a GMP Maintenance Technician who is ready to make an impact in the pharmaceutical industry. In this exciting role, you'll be integral to ensuring that our production equipment operates efficiently and safely in compliance with cGMP regulations. Imagine being pivotal in keeping the machinery that makes life-changing therapies possible! Your daily activities will include maintaining, troubleshooting, and repairing a variety of GMP equipment, from filling stations to formulation machinery. You will have the chance to work closely with cross-functional teams and contribute to our mission of excellence. If you thrive in a fast-paced environment and want to be part of a culture that emphasizes continuous improvement and attention to detail, this position is for you! In addition to your technical expertise, your proactive approach to preventive maintenance will help us minimize downtime and uphold our commitment to product quality. With the ongoing expansion of our state-of-the-art facility, this is an exciting time to join August Bioservices and grow your career while making a difference in global health. Let's unlock potential together and take the next step in your career with us!

Frequently Asked Questions (FAQs) for GMP Maintenance Technician Role at August Bioservices
What are the main responsibilities of a GMP Maintenance Technician at August Bioservices?

As a GMP Maintenance Technician at August Bioservices, you will execute preventive and corrective maintenance activities on production equipment, troubleshoot mechanical and electrical issues, and ensure compliance with GMP standards and regulatory requirements. Your role is crucial in maintaining operational continuity and product quality within our aseptic environment.

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What qualifications are required for the GMP Maintenance Technician position at August Bioservices?

To qualify for the GMP Maintenance Technician role at August Bioservices, you need a high school diploma or equivalent, with a preference for technical certifications in industrial maintenance or a related field. Additionally, you should have at least 2 years of experience in equipment maintenance within a GMP-regulated environment, along with a solid understanding of GMP and FDA guidelines.

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What experience should I have to apply for the GMP Maintenance Technician role at August Bioservices?

Candidates for the GMP Maintenance Technician position at August Bioservices should possess experience in troubleshooting and maintaining manufacturing systems, ideally in a pharmaceutical or biotechnology setting. Having hands-on experience with mechanical, electrical, and instrumentation repair will be highly beneficial.

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What is the work environment like for a GMP Maintenance Technician at August Bioservices?

At August Bioservices, GMP Maintenance Technicians work in a fast-paced and dynamic environment where teamwork and collaboration are key. You will be engaged in diverse tasks that keep our state-of-the-art facility running, while adhering to strict safety and regulatory protocols to ensure the utmost quality in our operations.

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What opportunities for growth does August Bioservices offer to GMP Maintenance Technicians?

August Bioservices is committed to the growth of our employees, including GMP Maintenance Technicians. With significant investments in expansion and new technology, there are ample opportunities to develop your skills, take on new responsibilities, and advance your career in the pharmaceutical industry as part of our talented team.

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Common Interview Questions for GMP Maintenance Technician
What experience do you have with troubleshooting GMP equipment?

In your answer, reference specific instances where you've identified and resolved mechanical or electrical issues in GMP equipment. Highlight your understanding of the processes involved and how your actions contributed to maintaining compliance and production schedules.

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Can you explain your understanding of GMP regulations?

It's important to articulate a clear understanding of GMP regulations, discussing how they apply to your past roles. You might highlight your familiarity with SOPs, documentation requirements, and regulatory oversight, showing how this knowledge ensures quality and compliance.

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How do you prioritize tasks during equipment maintenance?

Discuss your approach to prioritizing maintenance tasks based on urgency, regulatory requirements, and potential impact on production. Emphasize your organizational skills and ability to work effectively under pressure while ensuring all maintenance activities are conducted safely and efficiently.

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Describe a time when you worked as part of a team to solve a maintenance issue.

Share a specific example that showcases your collaborative skills. Outline the problem, your role in the teamwork process, and the outcome, highlighting how effective communication and cooperation led to a successful resolution.

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What is your approach to documentation and reporting in a GMP environment?

Emphasize the importance of accurate documentation in a GMP setting. Discuss your experience with maintaining logs, work orders, and calibration records, and how this practice supports regulatory compliance and operational efficiency.

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How do you ensure safety when performing maintenance tasks?

Your response should reflect your knowledge of safety protocols, including lockout/tagout procedures and PPE usage. Provide examples of how you've proactively mitigated risks during maintenance work and contributed to a safe working environment.

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What do you know about August Bioservices and our company culture?

Demonstrating research on August Bioservices' values and mission reflects well on you. Talk about how you align with their commitment to excellence, teamwork, and making a difference in global health, and how that inspires you to join their team.

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How do you handle equipment failures or emergencies?

Illustrate your problem-solving skills by discussing a specific emergency you faced. Detail your thought process, the actions you took to resolve the situation, and the lessons learned, showing your ability to remain calm and effective under pressure.

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Do you have experience with preventive maintenance programs?

Highlight your involvement in preventive maintenance initiatives, mentioning specific programs you've implemented or contributed to. Explain the benefits such programs brought to equipment reliability and overall production efficiency.

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What technical skills do you possess that make you a good fit for the GMP Maintenance Technician position?

Provide an overview of your technical competencies, ranging from mechanical and electrical repair skills to familiarity with validation and calibration processes in a GMP environment. Tailor your skills description to resonate with the specific needs at August Bioservices.

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Inclusive & Diverse
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Collaboration over Competition
Growth & Learning
Transparent & Candid
Medical Insurance
Dental Insurance
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DATE POSTED
April 20, 2025

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