SNBL USA, Ltd.

Validation Manager

SNBL USA, Ltd. is a leading contract research organization located just 30 minutes from Seattle, in Everett, WA. Through a commitment to investment and excellence, our team is able to offer the biotechnology and pharmaceutical industries high quality science and service. We have 275 employees and are continuing to expand with 100,000 sq ft of lab and office space to be completed the second quarter of 2006. Our organization is fueled by the talent of a diverse team of SNBL employees.

SNBL USA is looking for an experienced Validation Manager. This position will be responsible for the validation and/or qualification of Computerized Systems, operating in a GLP environment. Responsibilities include developing and executing validation test plans and protocols (IQ, OQ, PQ). Authoring other validation documentation, summarizing validation activities and reports, performing vendor audits and adherence to SOP’s and Corporate policies.

Responsibilities Include:

1. Prepares qualification/validations which should include, but are not limited to, a clear outline of responsibilities, the qualification/validation to be performed (Scope), acceptance criteria and task reports including statistical analysis where required per Company Standard Operating Procedures (SOPs).
2. Executes qualification/validation protocols.
3. Performs gap analysis and Part 11 compliance audits for existing (legacy) and future systems/software and document findings in Summary Report.
4. Maintains protocols in an orderly library so that information can be provided to regulatory bodies in a timely manner.
5. Develops, coordinates and executes computer system validation protocols for software systems that are governed by federal regulations, including 21 CFR Parts 210 and 211 with emphasis on 21 CFR Part 11 as applicable in the pharmaceutical industry.
6. Maintains Good Laboratory Practices, information security and regulatory compliance.

Education and Experience:

1. BS Degree in Engineering, Computer Science, Life Science, etc.
2. 5+ years of IT validation experience with quality software testing in GLP regulated environment.
3. Experience with testing of computer systems including data collection systems, i.e. LIMS, etc.
4. Extensive experience with GLPs, 21CFR Part 11 standards, and current regulatory requirements as they apply to information systems and applications.
5. Working knowledge of Microsoft office and project management tools (Word, Excel, Access) required.

For more information about SNBL USA, Ltd. visit our website at www.snblusa.com.

SNBL USA, Ltd. offers a competitive compensation and benefits package including health, life, and disability insurance, 401(k), Section 125, and a generous PTO package.

For consideration send cover letter and CV to: hr@snblusa.com.

SNBL USA, Ltd.
Attention: HR
6605 Merrill Creek Parkway
Everett, WA 98203
Fax: 425-407-1122
Email: hr@snblusa.com

SNBL USA, Ltd. is an Equal Opportunity Employer

Submitted: 03/15/2006