Senior CSV Specialist Job Details | Wacker Chemie AG

Wacker Chemie; San Diego (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

An innovative chemical manufacturing firm is seeking a Senior Computer System Validation Specialist to join their team in San Diego. This role offers the opportunity to lead and implement critical CSV projects that ensure compliance with industry regulations. The ideal candidate will possess a strong background in GMP and computer system validation, with a proven ability to manage projects independently. Join a company dedicated to creating sustainable solutions that impact daily life and be part of a collaborative environment that values diversity and innovation. Your expertise will contribute to shaping the future of the industry.

Benefits

Medical, Dental, and Vision Insurance

Paid Time Off

Paid Parental Leave

Flexible Hybrid Work Arrangements

401(k) with Company Match

Education Assistance Program

Wellbeing Fund

Career Development Opportunities

Qualifications

• 6+ years of experience in GMP/relevant industry.
• Experience in FDA regulated industry computer system validation.

Responsibilities

• Lead implementation of computerized systems and perform CSV validation activities.
• Support global computer system validation projects.

Skills

GMP Understanding

CSV Project Management

Statistical Analysis

Analytical Interpretation

Problem Solving

Communication Skills

Education

Bachelor's Degree in Science

MS/PhD in Relevant Field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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, end-to-end validation experience and application of project controls / management - including familiarity with all project lifecycle phases from requirements gathering through delivery, issues / risk management, change management, release management and retirement management.
• Experience with wide range of CSV experience including Manufacturing, Lab and Enterprise CSV experience.
• Implementing change initiatives and leading change.
• Statistical analysis
• Excellent analytical interpretation skills
• Risk-based application of validation principles
• Committed to delivering high quality results, overcoming challenges, focusing on what matters
• Strong problem solving and decision-making skills
• Good organizational skills and attention to detail.
• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.
• Ability to handle multiple assignments and changing priorities.
• Positive, proactive approach to drive assignments/tasks to completion.
• Proficiency with Microsoft Word, Excel, PowerPoint
• Ability or capable of lifting up to fifty (50) lbs.

The anticipated salary range for candidates who will work in San Diego is $100,000– 130,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi-state employer, and this salary range may not reflect positions that work in other states.

What do we offer? WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions. WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement

We are looking forward to your online application at www.wacker.com.
Reference Code:29283 LI-KM1 #IND123 The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card). WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.