Validation Engineer Position Available In Wake, North Carolina

Job Title:

Cleaning Validation Engineer – Drug Product (Parts Washers)

Location:

North Carolina, USA Duration:

12+ Months –

Onsite Overview:

Our client, a leading pharmaceutical manufacturer, is seeking an experienced Cleaning Validation (CV) Engineer to support cleaning validation efforts focused on drug product parts washers and autoclaves. The ideal candidate will have prior experience working in a CDMO or drug product manufacturing environment and possess strong expertise with Kneat for validation lifecycle documentation.

Key Responsibilities:

Act as the Cleaning Validation SME for drug product equipment such as parts washers and autoclaves. Collaborate with cross-functional teams including CQV, QA, QC, Operations, Supply Chain, and Process Support to align on cleaning validation requirements and execution strategies. Participate in CV-related discussions, ensuring alignment across all necessary functions. Liaise with Operational Readiness Teams and third-party contractors to integrate CV planning with cycle development and hold time strategies. Develop and document the site-specific Cleaning Validation Strategy. Write and review cleaning and sanitization procedures; maintain the Cleaning Validation Master Plan. Work closely with the CV team at the client’s European sister site to clone SOPs, validation methods, and documentation-then adapt for local use. Define and communicate roles and responsibilities during CV execution; secure cross-functional alignment. Assist in developing a communication strategy with the CV and CQV leads to ensure transparency across the site. Identify required SOPs, determine timelines, and coordinate with stakeholders to ensure timely completion. Work with QC to define and implement CV methods and sampling plans. Partner with Supply Chain to develop a materials strategy that supports CV (including sourcing and storage). Develop and execute a training strategy in collaboration with QC and Operations to prepare personnel for CV activities. Support implementation of the CV strategy across all functional areas with the help of CQV leads and QA. Define a documentation plan and coordinate with Kneat leads to ensure templates and document readiness. Localize all relevant documents and CV-related SOPs to the client’s North Carolina site. Conduct and support investigations of deviations or discrepancies related to CV execution.

Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or related field. Minimum of 5-7 years of cleaning validation experience in CDMO or drug product environments. Strong experience with Kneat and electronic documentation systems. Expert-level knowledge of cleaning validation principles, including autoclaves, parts washers, and sanitization in drug product manufacturing. Familiarity with regulatory expectations (e.g., FDA, EMA) and inspection readiness.