Senior Quality Engineer II, CSV job in Santa Monica, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Project Engineering, Project Management, Operations Management

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Quality Engineer II, CSV for a leading biotech company located in Santa Monica, CA. This is a great opportunity to join a team of highly motivated and innovative engineers in a hands-on position where you'll be leading data integrity initiatives for GxP regulated computerized systems.

Must be eligible to work in the US.

Job Responsibilities:

Leading the data integrity projects, which includes process mapping, data flow, identifying intended use of data, policy, and procedural gap assessments.
Providing guidance, planning and oversight on defining data integrity requirements for each computerized system based on patient safety, product quality and business criticality.
Supporting enterprise, cross functional, and local computer systems data integrity activities by providing approach, methodology and deliverables in compliance with data integrity principles, 21 CFR Part 11, and EudraLex Volume 4 Annex 11.
Partnering with project teams to identify the data integrity gaps of various computerized systems and providing solutions for bridging the gaps following a risk-based approach as established in policy documents and procedures.
Ensuring that GXP computer systems meet their respective data integrity requirements based on their impact to patient safety and product quality.
Acting as the quality reviewer for data integrity validation activities and deliverables.
Managing contractors performing data integrity compliance activities for systems and equipment.
Reporting status and progress of data integration activities to leadership team.
Supporting regulatory inspections and audits related to data integrity.
Driving continuous data integrity improvement initiatives.
5% - 25% domestic/international travel.

Skills and Requirements:

PhD OR MS plus 6+ years of experience in Engineering, Computer Science, or related field OR BS plus 8+ years of experience in Engineering, Computer Science, or related field.
PMP certification preferred.
Experience with implementation of data integrity solutions to maintain accuracy, consistency, and availability of data over the entire data system life cycle in GXP regulated environments.
Strong Knowledge of data integrity principles including ALCOA+, 21 CFR Part 11 and EudraLex Volume4 Annex 11.
Deep understanding of different types of computer systems (closed and open systems) and data (raw, static, dynamic, metadata).
Depth of understanding of relational data integrity models encompassing entity integrity, referential integrity, and domain integrity.
Demonstrated hands in experience in defining and executing data verification and data validation activities.
Proven track record to create, review, and execute qualification protocols (IQ/OQ/PQ) pertaining to data integrity.
Well-developed computer skills and fluent with Microsoft office applications.

If you are having difficulty in applying or if you have any questions, please contact Victoria Kroon at (+1) 929-387-4315 or v.kroon@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-VK1