Validation Engineer - Kentucky

About the role

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Senior CQV Engineer (Cleaning Validation & Data Integrity)

Location: Lexington, KY (Onsite) Duration: 6+ Month Contract Travel/Per Diem Available Industry: Pharmaceutical / Animal Health Manufacturing

About the Opportunity

Valspec is seeking a Senior CQV Engineer to support a high-impact Cleaning Validation and Data Integrity initiative at a pharmaceutical manufacturing facility in Lexington, Kentucky.

This consultant will lead validation activities supporting manufacturing suites, process equipment, and laboratory systems within a regulated GMP environment. The project includes development and execution of cleaning validation strategies, remediation planning, SOP creation, data integrity assessments, and cross-functional collaboration with Engineering, Quality, Manufacturing, and Laboratory teams.

The facility manufactures veterinary pharmaceutical products in powder, tablet, and granule dosage forms and operates multiple manufacturing suites as well as quality control laboratory operations utilizing HPLC, stability, incubation, dissolution, and analytical testing equipment.

Responsibilities

- Lead Cleaning Validation activities from planning through execution

- Develop and execute cleaning validation protocols and reports

- Design and support swab recovery studies and cleaning validation methods

- Establish worst-case product and equipment groupings using scientific and risk-based approaches

- Support protocol execution and field verification activities within manufacturing operations

- Author and revise validation documentation including:

- Validation Plans

- Risk Assessments

- Protocols

- Summary Reports

- SOPs

- Remediation Plans

- Evaluate existing cleaning procedures and implement improvements where necessary

- Perform Data Integrity assessments on laboratory systems and equipment

- Identify compliance gaps and develop corrective actions and remediation strategies

- Partner with Quality and Regulatory stakeholders to ensure alignment with current GMP expectations

- Support investigations, deviations, and change control activities related to validation programs