Senior CSV Specialist

  Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.   To strengthen our team in San Diego, we are looking for you as a(n) Senior CSV Specialist.

 

This is Us:

You know us. You just didn’t know it. WACKER is a global chemical manufacturer that prides itself on “Creating Tomorrow’s Solutions”. WACKER materials are so versatile and adaptable, they have virtually unlimited applications just about anywhere imaginable, making WACKER an integral part of daily life. Whether it’s protecting buildings from the elements, a tube of toothpaste, a cell phone, airbags, or cosmetics, people from all over the world come into contact each day with our products and achievements. We are looking for capable, innovative, and enthusiastic achievers to join our team and grow with us. We are currently seeking a Senior Computer System Validation (CSV) Specialist at the site in San Diego, CA.

 

What you will do:

The Senior Computer System Validation (CSV) Specialist is an essential position in the CSV team.  This position will be responsible of leading the implementation of lab instrument, manufacturing equipment and enterprise system that is used in Wacker Biotech San Diego site. 

 

The position will entail building strong cross-functional relationships throughout the organization and translating requirements into CSV project.  The role will also require supporting internal/external audits and other computer system lifecycle activities as required for the CSV program, as well as be responsible to develop and execute CSV lifecycle related deliverables with minimum supervision.This role will be leading the periodic review of validation computerized system and generate a periodic review report. This role will be supporting system owner on other computer system compliance activities like audit trail review, security review, and annual backup restore testing.

 

The Senior CSV Specialist will support global computer system validation project from the Global Bio-digital Solution team and provide Veeva QMS/EDMS/Training Vaults administration as required.

 

• Leading implementation of computerized system and perform CSV validation activities per WBU procedure.
• Perform CSV lifecycle activities including periodic review, audit trail review, security review, backup restore testing and other activities defined per WBU SOP.
• Support global computer system implementation and validation.
• Provide CSV support in deviation, CAPA, Change Control, and computer system vendor evaluation.
• Support regulatory filings and inspection as CSV SME.
• Support CSV remediation activities from external and internal audit.

 

 

What we need from you:

• Bachelor’s degree in science with 6+ years or MS/PhD with 4+ years of GMP/Relevant Industry Experience. (Chemistry, biochemistry, or related discipline preferred).
• Must have 4+ years of experience in pharmaceutical (FDA regulated industry) computer system validation.
• Ability to travel less than 10%.
• Proficient understanding of GMP, GAMP, Annex 11, 21CFR
• Lead and implement CSV project with minimum supervision.
• Must have strong hands-on, e