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Biotech Cleanroom Jobs in Kentucky (NOW HIRING)

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

... biotech, or medical device environment. * Demonstrated knowledge of FDA, EU, and ICH regulatory ... Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom ...

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

... biotech, or medical device environment. * Demonstrated knowledge of FDA, EU, and ICH regulatory ... Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom ...

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

... biotech, or medical device environment. * Demonstrated knowledge of FDA, EU, and ICH regulatory ... Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom ...

kindeva

Sr. Validation Engineer

Lexington, KY

... biotech, or medical device environment. * Demonstrated knowledge of FDA, EU, and ICH regulatory ... Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom ...

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Biotech Cleanroom information

What is the difference between Biotech Cleanroom vs Laboratory Technician?

AspectBiotech CleanroomLaboratory Technician
Required CredentialsCleanroom certification, life sciences trainingAssociate degree or relevant certification, lab safety training
Work EnvironmentControlled cleanroom environment, strict contamination controlStandard laboratory setting, varied equipment
Industry UsageBiotech manufacturing, pharmaceutical productionResearch labs, clinical testing

Biotech Cleanroom specialists focus on maintaining contamination-free environments for biotech and pharmaceutical manufacturing, requiring specialized cleanroom protocols. Laboratory Technicians support research and testing in general lab settings. While both roles require scientific knowledge, cleanroom roles emphasize contamination control and certification, whereas lab technicians focus on testing and data collection.

What are the key skills and qualifications needed to thrive as a biotech cleanroom technician?

To thrive as a Biotech Cleanroom Technician, you need knowledge of aseptic techniques, good laboratory practices (GLP), and a background in biology or biotechnology, often with an associate’s or bachelor’s degree. Familiarity with cleanroom protocols, environmental monitoring equipment, and compliance systems like GMP (Good Manufacturing Practice) is typically required. Attention to detail, reliability, and effective communication are critical soft skills for maintaining sterile environments and following strict procedures. These skills ensure product safety, regulatory compliance, and consistent quality in sensitive biotech manufacturing processes.

What are some common challenges faced when working in a biotech cleanroom environment?

One of the main challenges in a biotech cleanroom is maintaining strict adherence to contamination control protocols while performing complex tasks. Employees must follow rigorous gowning procedures, regularly sanitize equipment, and be vigilant about minimizing particle generation. The controlled environment can feel restrictive due to specialized attire and limited personal items, but it's essential for ensuring product quality and safety. Teamwork and clear communication are crucial, as tasks often require coordination with colleagues to maintain workflow efficiency and compliance with regulatory standards.

What is a biotech cleanroom?

A Biotech Cleanroom is a specially designed, controlled environment used in biotechnology labs and manufacturing facilities to minimize contamination from dust, microbes, or other airborne particles. These rooms maintain strict temperature, humidity, and particle count standards to protect sensitive biological samples and processes. Workers in biotech cleanrooms follow rigorous gowning and hygiene protocols, and equipment is regularly sterilized. Cleanrooms are essential in producing pharmaceuticals, medical devices, and other biotech products that require high levels of purity and safety.
What are popular job titles related to Biotech Cleanroom jobs in Kentucky? For Biotech Cleanroom jobs in Kentucky, the most frequently searched job titles are:
What job categories do people searching Biotech Cleanroom jobs in Kentucky look for? The top searched job categories for Biotech Cleanroom jobs in Kentucky are:
What cities in Kentucky are hiring for Biotech Cleanroom jobs? Cities in Kentucky with the most Biotech Cleanroom job openings:
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Sr. Validation Engineer

kindeva

Lexington, KY • On-site

Full-time

Re-posted 26 days ago

Kindeva rating

6.7

Company rating: 6.7 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activities—including equipment, utilities, facilities, and process validations—to ensure our operations remain compliant and inspection-ready. Your expertise in cGMP, risk-based validation, and technical writing will directly impact the safety, efficacy, and consistency of the drug products we deliver. This is a highly visible, hands-on role ideal for a detail-oriented professional passionate about quality and continuous improvement in a dynamic, fast-paced environment

Responsibilities:

Validation Strategy & Execution

  • Develop, execute, and maintain validation protocols and reports (IQ, OQ, PQ) for equipment, utilities, and manufacturing processes.
  • Support commissioning and qualification (C&Q) activities for new equipment and facilities, ensuring compliance with FDA, EU, and global regulatory expectations.
  • Author and review validation lifecycle documentation, including plans, protocols, deviations, and final reports.
  • Partner with Engineering, Manufacturing, Quality, and Regulatory Affairs to ensure effective cross-functional validation planning and execution.
  • Perform periodic reviews and revalidation activities in accordance with lifecycle requirements.

Compliance & Risk Management

  • Lead risk assessments (FMEA, gap assessments) to determine validation strategy and appropriate testing requirements.
  • Provide validation input during change control, deviation investigations, and CAPA execution.
  • Ensure data integrity and good documentation practices in all validation records.
  • Act as subject matter expert (SME) during internal and external audits and inspections.

Continuous Improvement

  • Evaluate validation program effectiveness and recommend process improvements to enhance compliance, efficiency, and scalability.
  • Stay current with industry best practices and evolving regulatory guidance to ensure validation activities remain aligned with expectations.

Qualifications:

  • Bachelor’s degree in engineering, life sciences, or a related technical field.
  • 5 or more years of validation experience; or 3 years with a Master’s degree 
    in a regulated pharmaceutical, biotech, or medical device environment.
  • Demonstrated knowledge of FDA, EU, and ICH regulatory requirements including 21 CFR Part 11 and Annex 15.
  • Experience in developing and executing validation documentation (IQ/OQ/PQ, protocols, reports).
  • Strong organizational, communication, and technical writing skills.
  • Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment.

Preferred Qualifications:

  • Familiarity with validation of automated systems and computerized system validation (CSV).
  • Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation.
  • Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva).
  • Lean Six Sigma or other continuous improvement training/certifications.

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