Validation Engineer

Yoh has a contract opportunity for a VALIDATION ENGINEER/SPECIALIST to join our client in Los Angeles, CA.

JOB OVERVIEW:

This individual must be versed in the principles and approaches of product/equipment CLEANING VALIDATION and will be responsible for providing hands on technical support to the Validation Manager in the design, development, and the implementation of a successful cleaning validation program meeting FDA requirements for products manufactured within the production facility. The cleaning validation program scope includes the cleaning of Semisolid (creams, gel and lotions) and Liquid products, including OTC products.

JOB RESPONSIBILITIES:

- Post cleaning validation monitoring, cleaning cycle development and cleaning validation (CIP/COP) in a cGMP facility.
- Maintains all documentation pertaining to cleaning cycle development and validation.
- Participates in cleaning cycle development activities for processing tanks including parameter selection, determining order of operations, troubleshooting, sampling, and data analysis.
- Coordinates validation execution between all involved departments.
- Independently follows-up and resolves comments, deviations, and technical issues.
- Authors development and validation protocols, SOPs, and reports.
- Reviews completed protocols for completeness, cGxP compliance and data acceptability; compiles final datapack.
- Reports progress and issues to team lead in an effective manner
- Generate and resolve protocol discrepancies or deviations
- Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation
- Train operations staff on protocols, procedures and technical details related to systems or processes

JOB QUALIFICATIONS:

- Bachelor's degree or equivalent from accredited university in Engineering, Science, Computer Science, or technical discipline.
- Three to ten (3-10) years of validation experience, with a strong emphasis in CLEANING VALIDATION and cleaning cycle development (CIP/COP).
- Experience in cleaning and process validation of OTC or NDA products within a FDA regulated production facility is preferred.
- Knowledgeable in cGXP's, validation principles, and change control.
- Must be able to analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the

agreed scope timelines, policies and procedures
- Proficient in the use of Microsoft Word, Excel, Visio and Outlook.
- Experience with Kaye Validator instrumentation a plus.
- Must be able to work independently with minimum supervision
- Have excellent oral and written communication skills
- Have proven leadership skills and an ability to work collaboratively across functional groups in the execution of project activities
- Problem solver; detail oriented, and must be able to handle multiple responsibilities and projects
- Must be flexible to work all shifts. Candidate will work a rotating schedule across 1st, 2nd, and 3rd shifts. Weekend work is required/mandatory

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Derek Bachmann

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

Tax Term: CON_W2

J2W: INFOTECH

J2WBRPHIL

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SFSF: LS