The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Computer System Validation Engineer in Bothell, WA \ Hybrid.

Role Description

Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements. · Author, review and/or approve applicable CSV documentation · Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures · Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations · Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required) · Other related duties as assigned

Skills & Requirements

• Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
• Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
• Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
• Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment. Education and Experience:
• Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
• Must have experience with Computer system validation of MES.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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