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Program Biotech Jobs in Kentucky (NOW HIRING)

kindeva

Sr. Validation Engineer

Lexington, KY

Continuous Improvement * Evaluate validation program effectiveness and recommend process ... biotech, or medical device environment. * Demonstrated knowledge of FDA, EU, and ICH regulatory ...

Adecco

Manufacturing Production Operator

Winchester, KY · On-site

$18.40/hr

Previous experience in manufacturing, biotech, or food manufacturing preferred. * Ability to ... EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the ...

kindeva

Quality Systems Specialist

Lexington, KY

Experience supporting quality systems, supplier quality programs, audits, compliance activities, investigations, and continuous improvement initiatives within regulated pharmaceutical, biotechnology ...

kindeva

Quality Systems Specialist

Lexington, KY

Experience supporting quality systems, supplier quality programs, audits, compliance activities, investigations, and continuous improvement initiatives within regulated pharmaceutical, biotechnology ...

kindeva

Quality Systems Specialist

Lexington, KY

Experience supporting quality systems, supplier quality programs, audits, compliance activities, investigations, and continuous improvement initiatives within regulated pharmaceutical, biotechnology ...

kindeva

Quality Systems Specialist

Lexington, KY

Experience supporting quality systems, supplier quality programs, audits, compliance activities, investigations, and continuous improvement initiatives within regulated pharmaceutical, biotechnology ...

Varsity Tutors

Agricultural Science Tutor

Lexington, KY · Remote

$40/hr

... and understanding biotechnology applications. Emphasizes scientific inquiry and connects ... Familiar with agricultural science curricula including FFA and vocational agriculture programs, and ...

Varsity Tutors

Agricultural Science Tutor

Louisville, KY · Remote

$40/hr

... and understanding biotechnology applications. Emphasizes scientific inquiry and connects ... Familiar with agricultural science curricula including FFA and vocational agriculture programs, and ...

Varsity Tutors

Life Sciences Tutor

Lexington, KY · Remote

$40/hr

... biotechnology career applications. * Curriculum Awareness & Adaptive Instruction: Familiar with ... programs. * Effective Teaching Methods: Ability to identify concepts students commonly struggle ...

Varsity Tutors

Life Sciences Tutor

Louisville, KY · Remote

$40/hr

... biotechnology career applications. * Curriculum Awareness & Adaptive Instruction: Familiar with ... programs. * Effective Teaching Methods: Ability to identify concepts students commonly struggle ...

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All JobsProgram Biotech JobsProgram Biotech Jobs in Kentucky

Program Biotech information

What is a Program Biotech?

A Program Biotech is a professional who manages and coordinates biotechnology projects or programs within an organization. They oversee research and development activities, ensure compliance with regulations, manage budgets, and facilitate collaboration between scientists, engineers, and other stakeholders. Their role is crucial in bringing biotech innovations from concept to market by ensuring projects stay on schedule and meet organizational goals.

What is the difference between Program Biotech vs Laboratory Technician?

AspectProgram BiotechLaboratory Technician
Required CredentialsBiotech degree or certification, specialized trainingAssociate degree or certification in laboratory sciences
Work EnvironmentResearch labs, biotech companies, pharmaceutical firmsClinical, research, or industrial labs
Employer & Industry UsageBiotech firms, research institutions, pharma companiesHospitals, research labs, manufacturing plants
Common Search & ComparisonYesNo

Program Biotech professionals focus on research, development, and overseeing biotech projects, often requiring advanced degrees and specialized training. Laboratory Technicians perform routine lab tests and support research or manufacturing processes, typically with an associate degree. While both roles work in lab environments within the biotech and healthcare industries, Program Biotech roles are more research-oriented, whereas Laboratory Technicians handle day-to-day testing and sample analysis.

What are some common challenges faced by Program Biotech professionals when managing cross-functional teams?

Program Biotech professionals often coordinate projects that involve diverse teams, including research scientists, regulatory specialists, and business development staff. One key challenge is ensuring clear communication and alignment among team members with varying backgrounds and priorities. Additionally, balancing project timelines with regulatory requirements and scientific uncertainties can require strong problem-solving skills. Being proactive in facilitating collaboration and adapting to shifting project goals are essential for success in this role.

What are the key skills and qualifications needed to thrive as a Program Biotech professional, and why are they important?

To excel as a Program Biotech professional, you need a solid background in life sciences, project management, and regulatory knowledge, often supported by an advanced degree in biotechnology or a related field. Familiarity with laboratory information management systems (LIMS), project management software, and compliance frameworks like GLP or GMP is common. Strong leadership, problem-solving abilities, and effective communication are crucial soft skills for coordinating multidisciplinary teams. These skills and qualifications are essential to drive innovation, ensure regulatory compliance, and achieve successful outcomes in complex biotech projects.
What job categories do people searching Program Biotech jobs in Kentucky look for? The top searched job categories for Program Biotech jobs in Kentucky are:
What cities in Kentucky are hiring for Program Biotech jobs? Cities in Kentucky with the most Program Biotech job openings:
Program Biotech jobs near you

Sr. Validation Engineer

kindeva

Lexington, KY

Other

Posted 4 days ago

Kindeva rating

6.8

Company rating: 6.8 out of 10

Based on 6 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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