Validation Engineer - Kentucky

Job Type: [Full-time/Contract]

Valspec is seeking a highly motivated and detail-oriented Cleaning Validation Engineer to join our dynamic team. The successful candidate will play a crucial role in ensuring the cleanliness and compliance of our solid dose manufacturing processes through effective cleaning validation protocols.

• →Develop, execute, and oversee cleaning validation strategies and protocols for solid dose manufacturing equipment and processes.
• →Collaborate with cross-functional teams to establish cleaning validation requirements, ensuring alignment with regulatory standards and industry best practices.
• →Perform risk assessments and gap analyses related to cleaning processes, proposing and implementing corrective actions as needed.
• →Generate and maintain cleaning validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• →Conduct equipment qualification activities in coordination with the validation team.
• →Coordinate and execute cleaning validation studies, ensuring thoroughness and accuracy in data collection and analysis.
• →Investigate and resolve deviations related to cleaning processes, collaborating with Quality Assurance and Manufacturing teams.
• →Stay abreast of industry trends, regulatory requirements, and technological advancements in cleaning validation, providing recommendations for continuous improvement.
• →Participate in regulatory inspections and audits, providing support and documentation as required.

• Bachelor's or higher degree in a relevant scientific or engineering discipline.
• Proven experience in cleaning validation within the solid dose industry.
• Knowledge of regulatory guidelines and requirements related to cleaning validation (FDA, EMA, ICH, etc.).
• Strong understanding of biopharmaceutical manufacturing processes and equipment.
• Familiarity with risk-based approaches to cleaning validation.
• Excellent documentation and record-keeping skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Effective communication skills and the ability to collaborate with cross-functional teams.

• Certification in validation or related areas.
• Experience with solid dose and associated cleaning validation.

Join Valspec and contribute to the advancement of cutting-edge life sciences through your expertise in cleaning validation. We offer a collaborative and innovative work environment dedicated to fostering professional growth and development. Apply now to be a part of our dynamic team!